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The ultimate guide to the medical device single audit program (MDSAP)
This article is an excerpt from The ultimate guide to the medical device single audit program (MDSAP) ebook.
Table of contents
- What is MDSAP?
- History of MDSAP
- Who is responsible for the MDSAP?
- How does an MDSAP audit work?
- Audit sequence
- You got a nonconformity – now what?
- What does an MDSAP audit cost?
- Why choose the MDSAP certification process?
- Potential disadvantages of the MDSAP
- Ready to participate? – Here’s how to get started
- Completing a successful MDSAP audit
The Medical Device Single Audit Program (MDSAP) was designed and developed to allow a single audit of a medical device manufacturer to be applied to all country markets whose regulatory authorities are members of the program. The MDSAP provides efficient and thorough coverage of the standard requirements for medical device manufacturer quality management systems, and requirements for regulatory purposes (ISO 13485:2016). In addition, there are specific requirements of each medical device regulatory authority participating in the MDSAP that must be met:
- Conformity Assessment Procedures of the Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3)
- Brazilian Good Manufacturing Practices (RDC ANVISA 16)
- Medical Device Regulations of Health Canada (ISO 13485:2003)
- Japan Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No 169)
- Quality System Regulation (21 CFR Part 820), and specific requirements of medical device regulatory authorities participating in the MDSAP program.
This means that a report from a single MDSAP audit of a medical device manufacturer would be accepted as a substitute for routine inspections by all the member Regulatory Authorities (RAs) across the world. There are currently five participating Regulatory Authorities (RA) representing the following countries: Australia, Brazil, Canada, Japan and the USA.
In April, 2021, the RAs released an “Audit Approach” document (MDSAP AU P0002.006) that combines the formerly separate MDSAP Audit Model and Process Companion documents into a single guidance document. It includes guidance for assessing the conformity of each process and includes an audit sequence, instructions for auditing each specific process, and identifies links that highlight the interactions between the processes.
In March 2012 the US FDA announced that they had approved a final pilot guidance document “Guidance for Industry, Third Parties and Food and Drug Administration Staff: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program.” This allowed the owner or operator of a medical device manufacturing facility to be removed from FDA’s routine inspection work plan for 1 year upon completing a ISO 13485:2003 audit. This guidance document went into effect in June 2012, and was intended as an interim measure while a single audit program was being developed.
This pilot program was not very successful and few companies signed up because they did not see any advantage in participating. The manufacturer had to pay for a third party to inspect their facilities, generate a report, and share the inspection results back to the FDA. Many companies were reluctant to contract “someone else” to perform their inspection when they could easily wait for the FDA to conduct an inspection for free.
During its inaugural meeting in Singapore in 2012, the International Medical Device Regulators Forum (IMDRF) appointed a working group to develop a set of documents for a harmonized third-party auditor system. Hence, the “Medical Device Single Audit Program” (MDSAP) was formed. The concept was similar to the FDA’s original idea of creating a third-party auditor to help reduce their workload of performing regulatory audits of medical device manufacturers’ quality management systems. This new approach would consist of a single audit that would review regulatory QMS compliance, conducted by a third-party, who would later be called an Auditing Organization (AO).
From January 2014 to December 2016, five countries participated in a Medical Device Single Audit Program Pilot. In June 2017, a report was generated summarizing the outcomes of prospective “proof- of-concept” criteria established to confirm the success of the program. The outcomes are documented in the final MDSAP Pilot Report and recommended that the program become fully active and open to any manufacturer who requested this type of audit.
The governing body of the MDSAP is the Regulatory Authority Council (RAC), which is composed of two senior managers (and a few other staff members) from each participating RA. They are responsible for executive planning, strategic priorities, setting policy, and making decisions on behalf of the MDSAP International Consortium. The RAC also reviews and approves documents, procedures, work instructions, and more. The mission of the MDSAP International Consortium is to jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers on a global scale.
Other international partners that are involved in the MDSAP include:
MDSAP Observers:
- European Union (EU)
- United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA)
- The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Program
MDSAP Affiliate Members:
- Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT)
- Republic of Korea’s Ministry of Food and Drug Safety
- Singapore’s Health Sciences Authority (HSA)
The observers and affiliate members are not the same as the participating member RA’s. The observers simply observe and/or contribute to RAC activities. Affiliate members, on the other hand, are interested in engaging in the MDSAP program and are subject to certain rules. They are only given access to a certain level of information about the manufacturers, audit dates, and information in audit reports.
They are also invited to attend sessions that are open to members, observers, and affiliates only.
Audits can also be conducted by MDSAP participating RAs at any time and for various reasons including:
- "For Cause" due to information obtained by the regulatory authority
- as a follow up to findings from a previous audit
- to confirm the effective implementation of the MDSAP requirements
The purpose of audits conducted by the RAs is to ensure appropriate oversight of the AOs MDSAP auditing activities. The AOs are appointed by the RAs and a list of the currently approved AO’s is published on the FDA website. Most AOs offer a broad range of management system certification services, beyond just medical devices. Manufacturers should verify that prospective AOs are clearly trained and perform MDSAP audits of medical devices.
AOs have the final word as to whether a manufacturer has met the requirements for the MDSAP during the execution of the audit and generation of the associated reports summarizing the results. MSDAP RAC participating RAs have the final decision regarding all development, implementation, maintenance, and expansion activities associated with the program.
Although an unannounced visit by an AO is rare, it can happen in circumstances where high-grade nonconformities have been detected.
To continue reading this eBook including a detailed look at the MDSAP audit process and grading, pros and cons of the approach, and how to get started please register to download the full version.
The beginner's guide to the FDA 510(k)
This article is an excerpt from The beginner's guide to the 510(k) ebook.
Table of Contents
- Introduction
- 510(k) basics
- Contents of a Traditional 510(k)
- 510(k) submission and timelines
- Other 510(k) forms
Congratulations! You have successfully developed a new medical device. Now you need to take it to market. In the United States, this often means submitting a 510(k). A 510(k) is a structured package of information about your device and its performance and safety that you submit to the Food and Drug Administration (FDA) for “clearance” before you can sell your device in the U.S. In order to receive clearance from the FDA, your 510(k) will need to demonstrate that your medical device is substantially equivalent to another legally marketed device (called a predicate device). The substantial equivalence approval process is a simple equation that looks something like this:
The 510(k) is generally the most efficient route to market clearance in the U.S. because you show your device is safe and effective based on this substantial equivalence standard, instead of needing to present more extensive clinical trial data.
There are three types of 510(k): Traditional, Abbreviated, and Special. This eBook will begin with a general overview of the 510(k) process, including its purpose and benefits. Next, we will explore the Traditional 510(k) and the sections and components required in depth. Finally, we will look at the Special and Abbreviated 510(k).
FDA: background and device oversight
Before we explain what a 510(k) is let’s first talk generally about the FDA and device oversight. The FDA is the U.S. governmental agency responsible for overseeing medical devices, drugs, food, and tobacco products. When it comes to medical devices, the FDA’s mission is to “protect the public health by ensuring the safety, efficacy, and security of…medical devices.” At the same time, the FDA also has an interest in “advancing public health by helping to speed innovations.” In other words, the FDA’s goal is to make sure devices are safe and effective for public use, while also ensuring that devices have a quick and efficient path to market.
In order to achieve this balance of safety and efficiency, the FDA has three different levels of oversight depending on the risk level of the device: (1) exempt from premarket submission, (2) Premarket Notification, also known as 510(k), and (3) Premarket Approval (PMA).
When is a 510(k) required?
A 510(k) is required for medium risk devices that have a predicate on the market which can be used to demonstrate the safety and effectiveness of the new device. Meanwhile, a PMA is required for high-risk or novel devices which require a higher level of scrutiny to be confirmed safe and effective.
A 510(k) is not only required for new devices, but also for devices that have been modified in a way that could impact safety or effectiveness. This could include changes to the:
- Design
- Components
- Materials
- Chemical composition
- Energy source
- Manufacturing process
- Intended use
You must submit your 510(k) at least 90 days before marketing the device.
What Exactly is Substantial Equivalence?
Now that we know what a 510(k) is, let’s talk about the substantial equivalence standard. You’ll recall from the introduction that your 510(k) must show that the new (or modified) device is substantially equivalent to at least one other legally marketed device, called a predicate device. Substantial equivalence looks at the intended use and the technological characteristics of the two devices.
More specifically, you must show:
- that the new device has the same intended use as the predicate, and
- the differences between the two devices do not raise questions about the safety and effectiveness of the new device.
Now let’s take a closer look at intended use and technological characteristics.
Intended use
Intended use means the general purpose or function of the device. The FDA will look at your proposed labelling and your Indications of Use section of the 510(k) to determine the intended use of your device (this is covered in Chapter 2). Intended use includes:
Technological characteristics
Once the FDA has determined that a predicate device exists and that the new device and the predicate device have the same intended use, it will move on to compare the technological characteristics. Technological characteristics include:
- Materials
- Design
- Energy source
- Other device features
The two devices do not have to be identical, and in fact they almost never are. The key here is to demonstrate that any differences do not have a significant impact on safety or effectiveness. Here’s what to cover when you compare your device’s technological characteristics with that of the predicate device:
Overall description of the device design
- Engineering drawings or diagrams to explain the device and component parts.
- List of component parts and explanation of how each component contributes to the overall use and function of the device.
- Physical specifications: dimensions, weight, temperature, tolerances, etc.
Materials
- Detailed chemical formulation used in all materials of constructions (especially those that come into contact with a patient).
- Any additives, coatings, paint, or surface modifications.
- How materials have been processed and what state they’re in.
Energy Sources
- Use of batteries, electricity, etc.
Other technological features
- Software/hardware
- Features
- Density
- Porosity
- Degradation characteristics
- Nature of reagents
- Principle of the assay method
In deciding whether the differences in technological characteristics impact safety or effectiveness, the FDA will typically rely on descriptive information about the technological characteristics as well as non-clinical and clinical performance data.
Let’s look at an example: A manufacturer submits a 510(k) for a new type of contact lens. Both the new device and the predicate device are indicated for daily wear for the treatment of astigmatism. The predicate device is only available in a clear lens, but the new device comes in a line of colors, including purple tinted lenses.
Who is responsible for submitting a 510(k)?
The following four types of organizations may be responsible for submitting a 510(k):
Manufacturers
- End-of-line device manufacturers who will be placing a device on the U.S. market.
- Note: Does not apply to component part manufacturers unless components will be marketed independently.
Specification developers
- Companies that develop the specifications for a finished device which has been manufactured elsewhere
Repackers or relabelers
- Required to submit a 510(k) if they significantly alter the labeling or condition of the device, including modification of manuals, changing the intended use, deleting or adding warnings, contraindications, sterilization status.
- Note: This is rare. The manufacturer, not the repackager or labeler, is typically responsible for the 510(k) submission.
Importers
- Importers that introduce a new device to the U.S. market may need to submit a 510(k), if it hasn’t already been submitted by the manufacturer.
Now that we’ve covered the basics, let’s explore what actually goes into your 510(k).
A Traditional 510(k) should contain all the following components in the list below. In some cases, a particular section may not apply to your device. When that happens, it’s a good idea to include the section anyway and just state “This section does not apply” or “N/A” under that heading.
To continue reading this eBook including a detailed walk-through of all the Traditional 510(k) components, submission requirements and timelines, and an overview of the other 510(k) forms including the Abbreviated 510(k) and the Special 510(k), please register to download the full version
The ultimate guide to the China UDI system and database
This article is an excerpt from The ultimate guide to the China NMPA UDI system and database ebook.
Table of Contents
- Overview
- UDI basics and benefits
- UDI format requirements and issuing entities
- UDI database and submission requirements
- Implementation of UDI and the UDI database in China
The current Chinese medical device regulatory regime kicked-off in 2014 with the Regulation on Supervision and Administration of Medical Devices. This core set of registration requirements, modeled after the United States and European Union systems, established a set of device classifications (class I, II, and III) based on risk and procedures for obtaining market clearance for each type of device.
Medical devices in China are regulated by the National Medical Products Administration (NMPA). Class I devices, such as clinical laboratory equipment or non-invasive skin dressings, require only notification to the NMPA for marketing authorization, and that authorization does not expire. Class II and III devices such as implantable devices or devices with a measuring function require full registration and a formal review before market clearance can be obtained.
These initial regulations have been expanded since their introduction, adding accelerated pathways to market for certain products in certain regions, easing acceptance of clinical data from overseas, and more specific roles and responsibilities for local agents of international manufacturers. In addition, in 2019, the regulations added a provision that medical devices carry a unique device identification (UDI). China’s UDI requirements are similar to those in the US and European Union. They establish specific device ID and labeling requirements, as well as a central, state-administered database of devices.
This eBook walks through the basics of medical device UDIs, the specifics of China’s implementation, and how MedTech companies who market their devices in China can prepare for the full rollout of these regulations in the coming years.
A UDI is a unique alphanumeric code that is designed to identify medical devices sold in a particular country/region from manufacturing, through distribution, to use by a patient. Like other aspects of the medical device regulatory regime, the UDI system in China follows the approach taken by the United States FDA and European Commission, and is based on the guidance from the International Medical Device Regulators Forum (IMDRF). Generally, UDI systems are designed to improve patient safety and optimize care by:
- Increasing the traceability of medical devices, including field safety corrective actions
- Providing an unambiguous identification method for medical devices throughout distribution and use
- Making adverse event reports more accessible
- Reducing medical errors by providing detailed information related to the device
- Simplifying medical device documentation and making it more consistent
There are three components to the UDI system in China:
- UDI code: The actual UDI code can be assigned by one of three (3) issuing agencies and contains information about the product, it’s expiration date, and the manufacturing batch/lot it’s associated with.
- UDI labeling: Put simply, medical devices must carry the UDI code on them. The regulations stipulate how devices and their packaging must be labeled for compliance.
- UDI database: In addition to labeling, all device UDIs must be submitted to a central database that is administered by the NMPA.
The following sections explore each of these components in more detail.
The UDI code
The first element of the UDI system is the code itself. The UDI code is the alphanumeric identifier that is associated with a specific medical device. UDI codes have two (2) elements to them, the UDI device identifier (UDI-DI) or static portion, and the UDI production identifier (UDI-PI) or dynamic portion. You can see the two components in the UDI diagram below:
The UDI-DI contains information about the issuing entity—the organization that is authorized to assign UDI codes. In China, this can be one of three entities: GS1, an international barcode and electronic data interchange standards organization, and two domestic organizations: the Zhongguancun Industry & Information Research Institute (ZIIOT), and AliHealth. Additional details about the issuing agencies are covered in Chapter 2. In addition, the UDI-DI contains information about the manufacturer and the specific model or version of the device.
The UDI-PI contains information about the manufacturing and production of the device. This typically includes information about the lot or batch number in which the device was manufactured, the manufacturing date and expiration date for the device (if applicable), and the specific serial number for the device. Here you can see all of the components marked up using the same UDI example:
Note that each packaging permutation and level for a given device will need to be assigned its own UDI. So for example, let’s say that a company manufactures 5ml enteral (oral) syringes in two packaging options: 1 – packaged individually and 2 – packaged in a box of 5. Each packaging option would need its own UDI, despite the fact that the underlying product is the same.
Now looking at packaging levels, let’s assume that the manufacturer packages the single syringe offering into boxes of 6, and again into larger containers of 24. Each of those packaging options needs its own UDI as well.
Labeling
In addition to obtaining UDI code for each device as outlined in the previous section, medical device manufacturers are required to ensure that devices are appropriately labeled with the assigned UDI. This label is called the UDI Carrier. The UDI is represented in two forms on the UDI Carrier: a machine-readable form and a human-readable form.
The machine-readable form or automatic identification data capture (AIDC) is a barcode or some other technology that can be used to automatically capture UDI information. The NMPA regulations support 3 types of machine-readable formats: 1-dimensional barcode, 2-dimensional barcode, and radio-frequency identification (RFID).
The regulations note that “use of advanced automatic identification and data collection technologies is encouraged”—prompting manufacturers to use more modern 2D and RFID machine-readable carriers where possible. Note, however, that if a device uses RFID, the UDI Carrier must also include the UDI in barcode format.
The human-readable form or human-readable interpretation (HRI) is the numeric or alphanumeric code for the UDI that can be read and manually entered into systems.
The UDI Carrier should be included on the device and on all levels of packaging. The UDI Carrier must be clear and readable during the operation and use of devices. If there isn’t room on the device for both the human and machine-readable forms of the UDI, then manufacturers should prioritize the machine-readable form.
UDI database
The third component of the NMPA UDI system is the UDI database. This is a centralized database of UDI and product information, administered by the NMPA. Manufacturers are required to submit UDI information into the database within 60 days after a product is approved (for sale in China) and before it is commercialized. The database contains a more detailed product record than what is included in the UDI itself, and it is the responsibility of the manufacturer (and/or their in-country representative) to submit the information correctly, and ensure that it’s kept up to date.
Chapter 3 of this eBook goes into detail about the specific fields and data requirements for UDI database submissions.
To continue reading this eBook including information about UDI format requirements and issuing entities, implementation timelines, and affected device types, please register to download the full version.
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Introducing Rimsys Intel: A Free, Centralized Global Regulatory Intelligence Hub for Medtech
Rimsys is excited to announce the beta launch of its community-driven, centralized hub for regulatory intelligence data, Rimsys Intel. Rimsys Intel builds upon Rimsys’ mission of increasing the availability of life-changing medical technologies by giving users free access to regulatory intelligence, including regulatory affiliations, legislation, UDI requirements, risk class information for medical devices and IVDs, in addition to market access requirements for each regulated country.
As part of our core company value to empower each other, Rimsys believes that regulatory intelligence should be easily accessible and free. I’m thrilled to provide a solution that enables medtech teams to make more informed decisions about market access for their products and execute faster.
To help keep Rimsys Intel up to date amid evolving global regulations, Rimsys is engaging RAPS Regulatory Affairs Certificate (RAC) holders. RAPS, the largest organization of regulatory affairs professionals in the life sciences industry, offers this credential to regulatory affairs professionals who demonstrate proficiency in the scope and application of medical device and pharmaceutical regulations. RAC holders who sign up for and review Rimsys Intel data will have the opportunity to earn recertification credits that count toward maintaining their RAC status.
As Rimsys participates in RAPS Euro Convergence this week, I’m proud to be among its community of inspiring, helpful, and knowledgeable innovators. Our collaboration with RAC holders is a very exciting and mutually beneficial one. Not only is the medtech community able to leverage regulatory intelligence verified by highly regarded RAC holders, but we’re also giving RAC holders a free way to earn recertification credits and further their professional development.
From solopreneurs to enterprise-level medtech companies, Rimsys Intel is equalizing access to global regulatory intelligence data by making it free for the community. Rimsys Intel is currently open to a limited number of beta users. Those interested in signing up for Rimsys Intel can join the beta waitlist here. Rimsys Intel will become generally available later this year.
Evolving global cybersecurity regulations: Challenges and opportunities for medtech teams
The landscape of medical device regulations continues to undergo significant changes globally. Most recently, there have been some noticeable shifts in how regulators are approaching the cybersecurity of medical devices. Recent updates from leading regulatory bodies, including the U.S. Food and Drug Administration (FDA), the European Union (EU), and the International Medical Device Regulators Forum (IMDRF), signal a united front in the drive to enhance the cybersecurity measures of medical devices.
The essence of these updates is clear: Cybersecurity is considered a fundamental aspect of medical device safety and efficacy. The FDA's proposed guidance adjustments, the EU's stringent requirements under the MDR and IVDR, and IMDRF's global harmonization efforts are reshaping the regulatory requirements for a broad range of device types. These changes underscore the importance of integrating robust cybersecurity protections from the earliest stages of device design to their operational lifespan.
With the ever-increasing incidents of security perimeter and data breaches, this transition while warranted, presents challenges for manufacturers to elevate their cybersecurity practices, to innovate with security in mind, and to navigate a complex global regulatory landscape. Yet, it also opens up opportunities to lead in the development of safer, more secure medical technologies that earn the trust of patients and healthcare providers alike.
FDA Cybersecurity Guidances
In the evolving landscape of medical device regulation, the FDA has proposed pivotal updates to its cybersecurity guidance, aiming to fortify the resilience of medical devices against cyber threats. This move reflects the growing interconnectedness of medical devices and the escalating sophistication of cyber threats targeting the healthcare sector. The FDA's draft guidance, "Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act," introduces an entirely new section dedicated to enhancing device cybersecurity throughout its lifecycle. This update emphasizes the criticality of integrating cybersecurity measures from the design phase through the entire lifespan of the device, encompassing premarket authorization, 510(k) clearances, De Novo requests, and more.
One of the significant highlights from the FDA's proposal is the emphasis on ensuring that devices capable of internet connectivity, whether intentionally or unintentionally, maintain stringent cybersecurity safeguards. This perspective stems from an understanding that the ability to connect to the internet inherently poses potential cybersecurity risks. It also expands best practices for cybersecurity within the medical device sector, building on the earlier adoption of a Secure Product Development Framework (SPDF). This framework aims to minimize vulnerabilities in medical devices by incorporating robust processes throughout the product development lifecycle. The guidance also stresses the importance of transparency, urging manufacturers to provide users with comprehensive cybersecurity controls, potential risks, and technical details through labeling. This approach is intended to empower users to manage cybersecurity risks effectively and respond promptly to any identified issues.
In addition to the FDA updates to cybersecurity guidance within medical device regulations, similar positions have been taken by other global regulatory bodies, recognizing the critical importance of cybersecurity in medical devices. As these frameworks get enacted and updated, the industry is seeing a unified drive toward enhancing the cybersecurity of medical devices, reflecting the global nature of both healthcare and cyber threats.
European Union (EU) Cybersecurity Guidelines
The European Union has continued to be proactive in addressing cybersecurity concerns through the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). The MDR, which came into full application in May 2021, and the IVDR, fully applicable from May 2022, incorporate specific requirements for ensuring the cybersecurity of medical devices. These regulations require manufacturers to consider cybersecurity at all stages of a device's lifecycle, from initial conception to decommissioning.
More recently, the EU has introduced updates to the Cyber Resilience Act and drafted a new EU cybersecurity rule to establish a European cybersecurity certification scheme (“ECCS”). The ECCS would introduce a detailed certification process, prohibiting self-assessment even for low-risk products. It mandates vulnerability disclosure for certified products, sets rigorous expectations for regulators and certification bodies, including regular product sampling and peer assessments, and requires a proactive approach to vulnerability management. The ECCS also would allow for the mutual recognition of standards internationally and mandate the consolidation of existing national certification schemes. This comprehensive approach highlights the EU's commitment to enhancing cybersecurity across the board.
IMDRF Cybersecurity Guidelines
The International Medical Device Regulators Forum (IMDRF) has also published guidance aimed at harmonizing cybersecurity practices. The IMDRF's guidelines focus on principles for medical device cybersecurity, which include risk management, post-market surveillance, and information sharing amongst stakeholders. These guidelines serve as a reference point for both regulators and manufacturers, aiming to foster a unified approach to addressing cybersecurity risks.
Impact on Device Manufacturers
Manufacturers must navigate these evolving regulatory landscapes, ensuring their devices comply with each jurisdiction's specific requirements. This means incorporating robust cybersecurity measures from the design phase through the entire product lifecycle. Expectations include the ability to update and patch devices in the field, conduct thorough risk assessments, and maintain transparency about a device's cybersecurity measures. The impact of these changes means that medtech design and commercialization pipelines will need to incorporate cybersecurity as a core component, rather than an afterthought. Manufacturers should anticipate:
- Increased Scrutiny: Regulatory submissions will likely require more detailed cybersecurity information, including evidence of risk assessments and mitigation strategies.
- Lifecycle Management: There will be a need for plans to address cybersecurity throughout a device’s lifecycle, including mechanisms for providing updates and patches.
- Global Harmonization: While regulations may vary in specifics from one region to another, the overarching principles of ensuring device safety and effectiveness through cybersecurity measures are consistent. Manufacturers looking to enter multiple markets will benefit from developing products that meet high cybersecurity standards capable of satisfying various regulatory requirements.
The Path Forward for Medtech Cybersecurity
As medical devices become increasingly interconnected and reliant on digital technologies, the importance of cybersecurity cannot be overstated. The FDA’s, European Union’s, and IMDRF’s updates are part of a broader global movement towards securing medical devices against cyber threats. Manufacturers must stay informed about these regulatory changes, integrating cybersecurity into every stage of their device’s development and lifecycle in order to properly comply with regulatory requirements.
Manufacturers and stakeholders should also closely monitor developments in cybersecurity regulations across all jurisdictions where they operate or plan to market their devices. Engaging with regulatory bodies, participating in industry forums, and adopting best practices in cybersecurity will be key strategies for navigating these evolving landscapes successfully and ensuring the trustworthiness and resilience of medical devices in the digital age.
FDA listed, cleared, approved, granted - what IS the difference?
The terms “listed," "cleared,” “approved,” and “granted” all refer to a finding or status from the FDA that authorizes a medical device to be legally placed on the market (for sale) in the United States. As a result, these terms tend to be used interchangeably, but they definitely don’t mean the same thing. Each references a unique pathway to market that is based on the device’s risk class. This article explains the differences between each term and what level of FDA review they require.
Market pathways depend on device classification
A business that is involved in the production and distribution of medical or in vitro diagnostic devices (intended for distribution and use in the United States) is required to register its establishment annually with FDA, using a process called establishment registration. This process requires putting information into an FDA database on their website. This also requires the business to list the devices and the activities performed on those devices, at their establishment. But before you can do this, you need to identify the proper classification of the device(s).
The FDA uses three levels of classifications for medical devices - each carrying a different patient risk value. Once the correct classification is determined, you must then choose the proper registration pathway – Premarket Notification (otherwise known as 510(k)), Pre-Market Approval (PMA), or De Novo process. Before you can legally market your device in the US, it must be FDA Cleared or Approved or in the case of the De Novo process, Granted.
What do the different FDA terms mean?
Regulatory professionals hear the terms Registered, Cleared, Approved, and Granted throughout the medical device industry, and even they are sometimes confused about the differences between them. However, the distinctions are significant, and it’s important to understand those differences and how and when to use them.
- Registered/Listed: A company that has registered with the FDA and has listed their device and the activities performed on those devices at that establishment, into the FDA's registration and listing database. It applies to all class devices, but for most of the Class I devices, it is the only form of registration with FDA. Important to know: the FDA does not issue any type of device registration certificates to medical device facilities.
- Cleared/Clearance: Most of the Class II and some Class I devices require a Pre-Market Notification (510(k)) submission. Before you can sell a device to the public, each submitter must receive an order, in the form of a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be sold in the U.S. This order clears the device for commercial distribution.
- Approved/Approval: A premarket approval (PMA) is the hardest type of device marketing application required by FDA for class III medical devices. To be legally sold on the market, they must undergo an extensive review and approval process. Following a successful submission of a (PMA) or a Humanitarian Device Exemption (HDE), the device is given Approval by FDA.
- Granted: Medical devices using the De Novo process will be Granted approval by FDA before they can be legally marketed in the United States.
Most Class I and some Class II medical devices are exempt from 510k submission requirements.
All other Class II devices require 510(K) clearance as a premarket submission to FDA to demonstrate that the device is safe and effective. Clearance is based on the device being substantially equivalent to an existing, legally marketed device, that does not require premarket approval (PMA). Medical devices in the 510(k) category receive an FDA clearance to bring the device to market.
All Class III devices require a Pre-Market Approval (PMA) - the most stringent type of device marketing application required by FDA. Premarket approval is the required process of scientific review to ensure the safety and effectiveness of Class III devices. Medical devices in this category receive FDA approval to bring the device to market.
Novel devices that don’t have a predicate on the market are classified as Class III by default. However, companies can use the De Novo process to request that the FDA review the risk and safety information of the device for possible re-classification. When a De Novo request is granted, the device is re-classified as Class II, and the device may be brought to market.
Companies can also submit a Humanitarian Device Exemption (HDE) application for Class III devices. A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 individuals in the United States per year. The HDE application is like a PMA application, but it is exempt from the effectiveness requirements of a typical PMA.
A relatively newer term being used now is the Emergency Use Authorization (EUA). This is when the Secretary of Health and Human Services declares that there may be circumstances justifying the authorization of emergency use of medical devices, such as during the COVID-19 pandemic. The FDA may issue an EUA to authorize unapproved medical products (or unapproved uses of approved medical products) so that they can be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain criteria are met.
Checking the status of a device with the FDA
The FDA provides several ways to check if devices are approved, cleared, or granted.
To search for FDA-approved or FDA-cleared products by device name or company name:
- Go to the Devices@FDA Database.
To search for FDA-granted products by device name or company name:
- Go to the Device Classification Under Section 513(f)(2)(De Novo) database.
To search for FDA Emergency Use Authorization devices, go to the listing here.
Conclusion
Terminology is only one of the things that can be confusing about the FDA’s processes. Using the wrong terminology can impact your company’s reputation, and possibly have some legal implications, but more importantly, it can mean that you don’t have a clear understanding of how to bring your product to market.
Making sense of the different FDA processes can be challenging—especially for companies that are bringing devices to the market for the first time. For a detailed walkthrough of the steps, documents, and timeline associated with each path to market, see our Beginners Guide to the 510(k), Beginner’s Guide to the FDA PMA Submission Process, and Beginner’s Guide to the FDA De Novo Process.
Learn why UDI is relevant to regulatory affairs and how Rimsys can help medtech RA teams manage the growing complexities associated with UDI data.
This article was last updated March 12, 2024.
What is UDI?
Unique device identifiers (UDI) are now a requirement for medical devices marketed in the US, and are being phased in by the EU and other countries. UDI systems are intended to benefit healthcare providers, manufacturers, authorized health authorities, hospitals and institutions, and individual consumers by providing:
- Faster discovery of possible flawed medical device information by health authorities.
- Quicker access to recall information, and visibility into current inventory.
- A reduction in medical errors through consistently documented product expiration dates.
- Identification of any counterfeit products being used in healthcare facilities.
- Assurances that information regarding an implanted device is safely retained and traceable.
UDI timeframes and deadlines vary by market and product, and have been revised multiple times in some countries. This article details the UDI deadlines for the countries which have announced specific programs, and is current as of the date of this article. Note that these dates can change as participating countries adjust their plans. We will continue to update this as more information becomes available.
Quick Links to country-specific sections:
- Australia UDI
- Brazil UDI
- Canada UDI
- China UDI
- European Union UDI
- India UDI
- Japan UDI
- Saudi Arabia UDI
- Singapore UDI
- South Korea UDI
- Taiwan UDI
- US UDI requirements
- UDI databases by country
The Australian Therapeutic Goods Administration (TGA) announced that mandatory compliance will be progressively phased by device classification, starting with high-risk and implantable medical devices, followed by lower risk class devices over subsequent years. Mandatory compliance will likely not go into effect until the Medical Device Regulations is updated in 2024.
Sponsors and manufacturers can choose to voluntarily comply with the UDI requirements from the date the UDI regulations take effect. Mandatory compliance will commence at a minimum of 12 months from the date the regulations take effect. The reporting database for UDI (AusUDID) is also still in the production phase.
On January 10, 2022, RDC 591/2021, the regulation that requires UDI labeling and database registration for devices regulated by the Brazilian Health Regulatory Agency ANVISA, came into effect. The regulation calls for rolling implementation based on risk class and the establishment of a Brazil UDI database. In June 2024, an amendment to the regulation was published in RDC 884/2024. The updated timelines are published for each risk classes II, III, and IV below. The amendment had no impact on the timeline for class I devices.
In the case of reusable devices for which the UDI information is placed directly on the product, an additional two years have been added to the transition periods below. Details of the UDI reporting database, and related compliance dates, are not yet available. Additional information can be found here: ANVISA UDI guidelines
Health Canada has proposed a UDI framework based closely on the international UDI guidance from the IMDRF. The current proposal involves requiring UDI labeling for all devices, with the exception of Class I low-risk devices. Health Canada intends to either develop a UDI database or modify the existing Medical Devices Active License Listing database (MDALL) to accommodate UDI data.
In addition to labeling requirements, China requires that the UDI be recorded in the China National UDI Database as part of the medical device registration. Additional information on China UDI requirements (link in Chinese) from the China State Drug Agency and Rimsys Ultimate Guide to the China NMPA UDI System.
According to the initial provisions of the European MDR and IVDR regulation, industry use of EUDAMED may not be mandated until all modules are declared fully functional. In the last several months, the MDR/IVDR amendment proposal (23/01/2024) was released to suggest a gradual implementation of individual EUDAMED modules once each has been audited and declared functional. This proposal has been issued with a goal to speed up launch of the modules of EUDAMED as each is finalized to allow for industry implementation and adoption without additional, undue delay. The UDI module of EUDAMED is available for voluntary use currently and, with the provisions of the proposed amendment, could be mandatory use for industry in late-2025 with an expected transition period beginning at the time the UDI module is ready. Additional information on EU UDI system and requirements: EU UDI system and requirements.
At the end of 2021, the Indian Ministry of Health and Family Welfare delayed the implementation of UDI requirements in India and no new deadline has yet been put in place. Originally, Rule 46 of Medical Device Rule 2017 was set to require UDI labeling by January 1, 2022 for medical devices approved for manufacture, sale, distribution, or import in India. Details on how the UDI needs to be displayed and the specific information that needs to be included have not yet been released.
Japan was an early promoter of standardized barcodes, but is still working towards harmonizing their requirements with global UDI expectations.
As of Dec 2022, according to the type of device, bar code labeling based on the international standards is required for immediate containers/wrappings/retail packages of medical devices. It is expected that barcodes would be displayed on every pharmaceutical and medical device in unit of use for patients. Also, safety measures using bar code labeling at clinical settings shall be promoted, as well as registration of production information in the database by MAHs.
Saudi Arabia has allowed voluntary UDI registration since October 1, 2020, but mandatory compliance for class B, C and D devices went into effect September 1, 2023. These requirements apply to both labeling and database (SaudiDI) registration.
Medical devices imported before the compliance date may be distributed without UDI information until one year after the date of full enforceability. This exception does not apply, however, to the Direct Marking (DM) requirement, which is a permanent marking of the UDI on the device itself. For additional information, refer to the Saudi Arabia guidance document.
Singapore is requiring compliance with UDI labeling or database registration regulations based upon classification and a phased in approach. Singapore will accept UDI labels for devices already marketed in the U.S. and the EU, otherwise the UDI will need to comply with all of Singapore’s HSA guidelines, including partnering with an HSA-designated UDI issuing entity. Singapore is also allowing companies a 6-month grace period for medical devices imported before the November deadlines listed below.
Guidance on Medical Device UDI system (GN-32-R2)
UDI compliance is mandatory and was implemented by Article 20 of Medical Device Act (No. 14330) and Article 54-2 of Enforcement Regulations of Medical Device Act (No. 1512). Note that South Korean regulations refer to “Integrated Medical Device Information System,” or IMDIS, which is their UDI database and “Medical Device Standard Code,” which is the UDI code itself. As part of the introduction of UDI, South Korea has also mandated that manufacturers provide a device monthly supply history report, required 1 year from the UDI compliance dates.
South Korean regulations: Guidelines for generating UDIs, Medical Device Act No. 14330 and the Regulation on KGMP No 2016-156 (links in Korean).
Taiwan has already implemented UDI regulations, which includes both labeling and database reporting requirements. The UDI reporting database is referred to as Taiwan UDID (TUDID) and has 23 required data elements. If medical materials meet one of the following conditions, however, then they could be exempt from UDI: Customized medical devices, special medical equipment for export and non-implantable medical device components in the medical device package and in vitro diagnostic medical device package for single use only and not used separately and sold. Read more in the Guidance document from Taiwan FDA.
The United States mandates compliance with both labeling and database requirements for all devices. The FDA does not intend to enforce the GUDID submission requirements for Class I and unclassified devices, other than implantable, life-supporting or life-sustaining devices (I/LS/LS), regardless of whether they were consumer health products, before December 8, 2022.
Implantable, life-supporting or life-sustaining devices, including Class I I/LS/LS devices, should also be complying with GUDID submission requirements. The US FDA requires that all UDI information be entered into the US-specific GUDID database. For additional information, see the FDA UDI system and requirements.
Each country has their own UDI database and varying requirements for the data stored in those databases. There is overlap in the data required among the various UDI databases, but each country also has unique data they require.
In addition, countries require that UDI-DI information be provided by “issuing entities.” Note that with the exception of China, all countries accept GS1, HIBCC, and ICCBA as issuing entities.
Note: * Data attributes are approximations based on country UDI requirements and include mandatory, optional, mandatory if applicable, and country database auto generated elements.
** Expected to be similar to US GUDID requirements.
Keeping pace with UDI regulations
Keeping track of country-specific UDI requirements, implementation timelines, and affected devices can be a big challenge to RA teams—especially because the information is scattered across many sources and hard to find. In this guide, we have consolidated timeline information and device class requirements across multiple countries. While we make every effort to provide accurate and up to date information, it's always advised to check the government website for the country in question.
Additional UDI resources
Our team discussed country-specific UDI requirements and strategies that regulatory affairs teams can use to better manage UDI data in an in-depth webinar. For additional information on UDI requirements, you can watch the webinar replay here, or review our Ultimate Guide to the EU MDR/IVDR UDI and the Ultimate Guide to the China NMPA UDI System.
Key steps to help you streamline regulatory process management
Regulatory affairs is constantly changing, and these changes span the entire product lifecycle - from pre-market awareness of global regulations to managing varying and changing market placement and post-market activities. Managing all types of regulatory changes without streamlined processes and methods in place is a daunting task and one that can set regulatory affairs teams up for risks, including project delays, non-compliances, financial impacts, and employee turnover.
With regulatory affairs interactions and activities often spanning various departments, office locations, and external stakeholders, many regulatory affairs teams are left wondering how they can better streamline their process management.
We recapped core methodologies from our recent webinar, Navigating regulatory change: Why streamlined process management is critical for medtech regulatory teams, to help RA teams review their existing processes, identify gaps, and put together a remediation and implementation plan that will enable them to reduce risks and maintain regulatory continuity.
Phase 1 – Assess your team’s current processes
Assigning resources to provide an honest assessment of your regulatory processes can be tough. We've seen the most success by having awareness and involvement from all of your team’s stakeholders, as many of them have a vested interest in your regulatory processes and information. Additionally, we've seen even greater success when those efforts are supported by an executive sponsor who's committed to streamlining these processes and making the changes.
When we talk about assessing current processes, we don’t just mean reading common SOPs and flow charts. We're talking about an honest review of the adequacy of your regulatory inputs. Some questions you can ask to help with your assessment are:
- Do we have everything that we need when we need it?
- Does this process generate valuable deliverables? How hard are we working to generate these outputs?
- Do we have the right tools in place? If not, what tools on the market can help us achieve our goals?
It’s safe to say you can spend less time on processes that you've identified are working well. If you don’t know exactly where to start in a process assessment, it's helpful to think about where you spend most of your time. When focusing on the processes that are taking up most of your time, it’s easier to see where the inefficiencies lie.
Once the opportunities for improvement are identified, it's time to consider all potential risks. Compliance risk is an important thing to consider, but there’s also business risk with slow processes, inefficient processes, or even worse, ineffective processes where RA professionals spend a lot of time arriving at the wrong output or no output at all.
As risk is assessed for these opportunities, you should then consider the effort that it's going to take to resolve each. This measurement doesn't have to be highly specific. The intent for it is to ultimately help you prioritize which regulatory process changes you want to execute with your team first.
Phase 2 – Planning for Improvement
While there is some planning that needs to take place at the time that you kick off the assessment phase to help you understand and establish who's going to assess which processes., this phase is intended to focus on planning for improvement. It starts with prioritizing your inefficient processes from highest to lowest. Gaps should be prioritized and resourced first without trying to “boil the ocean.” This will help your team set itself up for a successful implementation phase next. From our experience, it’s hard to appropriately focus on process improvement when trying to change too many processes at once.
Within the planning phase, you can review the results of the assessments with all of the regulatory stakeholders and any other stakeholders who are involved with the outputs of the processes. The process owners can then take this opportunity to break down silos by understanding the relationship that their processes have with other departments and the effect their outputs have on these departments. Taking the time to understand the impact your processes have on other departments will allow you to be able to make any necessary adjustments to the inputs and outputs of your processes and hone your communication strategies.
From here, you can assign resources and tasks to manage the overall effort with regular check-ins.
Phase 3 – Implementation
Implementation, the easy part as we jokingly say. As you work through the implementation tasks identified in the planning phase and check in with your stakeholders, it's a good idea to test and iterate on your changes to ensure that they continue to make sense. This is also crucial to verify that your changes are advancing the project or the task toward your overall process management goals.
Training is a key element in the implementation phase as well. Any upfront communication that can be provided to the users of the process ahead of the training is going to be beneficial for change adoption and change management. It’s important to not only communicate that process changes are coming but also why they are coming and what benefits the end users of the process and the consumers of the outputs expect to see as a result.
Once those process changes have been implemented, and training is completed, it’s important to measure and monitor the process for the effectiveness of the changes. Some key questions to consider here are:
- Did we gain efficiencies?
- Did we make our lives easier with these process changes?
- What impact have these process changes had on our team, other departments, and our organization?
If you can’t answer these questions positively, it’s important to go back through the assessment planning phase activities to make sure all improvement opportunities and tasks were properly identified and assigned. When you’ve found those changes have made a positive impact, you should communicate those successes with all relevant teams to build a success story within your organization and to encourage additional adoption of these changes.
Our webinar replay, Navigating regulatory change: Why streamlined process management is critical for medtech regulatory teams, has more tips to help you optimize your process management and explains how regulatory tools such as RIM systems can help RA teams automate, track, and manage their processes across global internal and external teams. Download the full replay here.
Rimsys UDI Overview
UDI: More than Just a Barcode and Label
Unique Device Identification (UDI) is a global requirement mandated by regulatory bodies in various countries to facilitate the easy tracking of key medical device information throughout the supply chain. This system ensures traceability from the moment a device is manufactured until it is used in a medical facility or at home.
The UDI system mandates specific labeling requirements, including the placement of a UDI number, a barcode, and essential device information on the medical device's label. This facilitates the straightforward identification and tracking of the device.
The importance of UDI to regulatory affairs teams
The obligations of the device labeler extend beyond just labeling. Manufacturers are also required to submit and update device information in regulatory databases specific to each country where the device is marketed. This part of the regulation underscores the importance of managing UDI data effectively, as it is critical for legally marketing and maintaining medical devices in different markets. As a result, the responsibility for UDI compliance is increasingly recognized as falling within the purview of regulatory affairs departments within manufacturing companies.
The Unique Device Identification (UDI) system, initially introduced by the US FDA, has since been adopted by regulatory authorities worldwide. These authorities are developing their own UDI programs tailored to their countries to deliver similar patient benefits. Each country's UDI program typically mandates specific labeling and device data reporting and maintenance. While there are overlapping elements for the UDI data required, individual countries have set up additional, localized requirements. This creates a layer of digital complexity through unique regulatory database requirements, interfaces for data entry, and the need for machine-to-machine submissions to handle large-scale reporting.
The increasing blend of shared and unique UDI data requirements, along with country-specific regulatory database needs, highlights the importance of developing comprehensive compliance solutions. The drive for digital transformation in this area is fueled by the intensive data demands from both regulators and manufacturers. This transformation aims to simplify the management of expanding requirements and address the growing complexity as more countries adopt UDI programs.
As UDI programs and the necessity for database reporting become mandatory in more countries, manufacturers and labelers must be ready to establish and maintain UDI datasets for both new and existing products in those markets.
How Rimsys can help
Rimsys regulatory management software offers a platform that simplifies the creation, maintenance, and reporting of UDI data. It also provides tools to oversee and manage the entirety of a company's UDI program through a unified solution.
Business outcomes supported by the Rimsys UDI module:
- Remove the risk of data entry error that comes with keeping identical data sets manually in sync - The Rimsys solution allows users to create and manage UDI attribute data from a centralized location and then apply that information to global UDI requirements, where the data requirements overlap multiple markets.
- Reduce the burden of keeping up to date with each country's UDI program - Rimsys monitors global UDI regulatory changes and adds new country requirements directly into the platform as UDI programs are implemented and become required. Rimsys also keeps up with the latest changes to supported UDI programs for the US (FDA) EU (MDR), Saudi Arabia (SFDA), China (NMPA), South Korea (MFDS), and Singapore (HSA) and updates the required fields directly into the platform.
- An open API ecosystem allows "source of truth" data to be integrated into Rimsys as a "post go-live" phase - Ensure data is up to date and locked at the source of truth, yet centralized for application to global UDI requirements in Rimsys. Data that is required but not controlled in a customer's source system can be managed within Rimsys.
- Built-in support of machine to machine (M2M) transmission to GUDID (FDA) with EUDAMED (EU) coming soon - Rimsys alleviates the need to manually upload UDI data into databases when relevant information changes to ensure compliance. Acknowledgments from machine-to-machine interactions are saved directly to Rimsys and associated to each UDI record.
- Leverage the existing product hierarchy in Rimsys to efficiently manage Basic UDI to reduce non-compliance risk for EU MDR - Data requirements for Basic UDI established in Rimsys are included with the M2M process - Coming Soon
- Facilitate impact assessments in Rimsys since UDI information sits alongside product and registration data - Eliminate the need to manually combine disparate data sets.
Ready to see how Rimsys software can help you create and manage the complexities of UDI data? Schedule a custom demo here.
