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FDA medical device registration process - getting new products to market in the U.S.

By

Wendy Levine

April 21, 2022

4 min read

FDA device registration overview

Registering a new medical device with the FDA can be a huge undertaking, and understanding the process and all of the requirements as early as possible is important. This article provides a high-level overview of the steps required before marketing and selling a medical device in the United States. We’ve done our best to include relevant links to both FDA documentation and educational materials wherever possible!

FDA medical device registration steps

Classify your medical device

Classifying your medical device should be one of the first steps in any FDA submission. The FDA classification system is a “predicate-based” system in which devices are classified based on similar devices that are already on the market in the U.S.

You may already have an idea as to which of the three device classes your product falls under, but you still need to determine the specific device category described within 21 CFR Parts 862-892. The FDA provides a good overview and listing of device categories that is searchable. This will allow you to determine which specific section of the regulation pertains to your device, which will then define the classification and relevant premarket requirements. While the majority of Class I devices require no premarket notification, the majority of Class II devices require 510(k) premarket notification, and the majority of Class III devices require a premarket authorization submission, however,this is not always the case. 

Medical device manufacturers can request information and guidance from the FDA regarding the classification of a device through a 513(g) request. For the classification of accessories to your device, a pre-submission may be more appropriate (discussed below) 

Collaborate with the FDA prior to your submission   

The FDA encourages pre-submission collaboration meetings and communication as early in the product development process as possible. It is in the best interest of organizations seeking approval of a medical device to have an open dialogue with the FDA, enabling the FDA to advise before and during the submission process, provide direction on Investigational Device Exemption (IDE) applications, and identify any potential concerns that may affect approval or clearance of the device. This is especially important for devices with novel technology.

There are a number of pre-submission activities defined in the FDA’s “Q-Submission” program (these were previously referred to as “pre-ide” meetings). Q-subs provide an organization with the opportunity to obtain feedback from the FDA before a premarket submission is made. The most common Q-subs are:

Pre-submission (pre-sub) requests provide an opportunity for an organization to obtain feedback from the FDA before completing a premarket submission. Pre-sub requests are made in writing to the agency and can involve a meeting if requested by the submitter. The submitter should have specific questions prepared regarding their submission and/or product development prepared for the FDA to review during this meeting. 

Informal Meetings are requests to share information with the FDA with no expectation of feedback. This may be helpful if your team has a variety of submissions planned, or if your company would like to explain the technology of your device. 

Early collaboration determination meetings are requests by a PMA applicant for the FDA’s determination of the type of valid scientific evidence required to demonstrate that the device in question is effective for its intended use.

Early collaboration agreement meetings are used to reach an agreement between the FDA and the submitter on key parameters of the investigational plan.

Results of early collaboration determination and agreement meetings are binding on the agency. For additional information, see “Early Collaboration Meetings Under the FDA Modernization Act: Final Guidance for Industry and for CDRH Staff”

Prepare the appropriate premarket submission for your medical device

Remember that most Class I devices, and some Class II devices require no premarket submission (though they are required to be listed with the FDA).

510(k) Premarket Notification is used for Class II and Class III devices with a medium risk profile for which there is a predicate, substantially equivalent, device on the market that requires a 510(k) submission.

The 510(k) submission is used to demonstrate that the predicate device is substantially equivalent to the new device and, if successful, results in an FDA “clearance” for the new device. You can read more in our FDA 510(K) beginner’s guide.

Premarket Approval (PMA) is used for Class III devices for which the identified predicate device requires a PMA. These are devices which are high risk; defined as a device that supports or sustains human life, is of substantial importance to preventing impairment in human health, or presents a potential and unreasonable risk of illness or injury. Novel devices which have no substantial equivalent on the market also require a PMA by default.

A PMA is intended to prove that a new device is safe and effective for the end user, and is much more detailed and in-depth than a 510(k). Device manufacturers are typically required to present human clinical trial data, in addition to laboratory testing data. A successful PMA results in an FDA “approved” device.

The De Novo classification process can be used for novel devices for which there is no substantial equivalent on the market, but which have the lower risk profile of a Class I or Class II device. A successful De Novo request is “granted” by the FDA and results in the classification of the device as Class I or Class II. You can read more in our De Novo classification process: a beginner’s guide.

Work with FDA staff during the review process

The more complex your submission to the FDA, the more opportunities you will have to interact with the agency during the review process. Take advantage of these opportunities and be sure to respond to any requests for additional information within the specified time frame. The 510(k) submission process and the PMA submission process both have defined procedures for requesting and submitting additional information during the review process. PMA submissions for devices with new technology may also require interaction with an expert review panel. 

If you need additional clarification from the FDA on your 510(k) or PMA submission, the following options are available: through the Q-submission process:

Submission Issue Requests (SIR) are Q-submission requests for feedback and clarification during a pre-marketing submission including 510(k), De Novo and PMA submissions. These are often held after a submitter receives letters from the FDA asking for additional information or deficiency letters. 

PMA day 100 meetings are Q-submission requests held within 100 days of a PMA submission and are used to discuss any deficiencies in the application, and to begin a conversation on the status of the application. FDA guidance on PMA day 100 meetings can be found here.

Complete a quality system audit

Most Class II and III devices, and some Class I devices will require a premarket quality system inspection. During most of the Covid pandemic, inspections were being conducted remotely, but the FDA resumed domestic onsite inspections in February 2022. 

A compliant quality system demonstrates that your facilities are capable of manufacturing the device as designed to meet its intended purpose, and the FDA will evaluate both design controls and manufacturing controls.

Current quality system requirements are defined in 21 CFR part 820 (quality system regulation or “QSR”), however the FDA is moving to harmonize their requirements with the generally accepted global standards of ISO 13485. In addition, the Medical Device Single Audit Program (MDSAP) can be used as an alternative allowing a single audit that is recognized by regulatory authorities in multiple countries, including the FDA.

Whichever path your inspection takes, it is important to put a strong quality system in place as early as possible.

List your medical device on your establishment registration

Any organization involved in the production or distribution of a medical device intended for use in the United States is required to register annually with the FDA. Establishment registration is defined in 21 CFR Part 807. There is an annual registration fee, which is $5,672 for 2022.

Most establishments that are required to register with the FDA must also list the devices and the activities performed on those devices at the establishment. Registration and listing information must be submitted to the FDA within 30 days of a device being put into commercial distribution. You cannot list your device until it has been cleared or approved through a premarket submission process, if required for your device.

The FDA provides detailed information on the device registration and listing process.

Post-market compliance

We will cover post-market surveillance and compliance in a future post, but here are a few things to keep in mind:

  • If your device was approved via a PMA, expect a post-market inspection 8-12 months after approval.
  • Changes to a cleared or approved product may trigger additional reporting and submissions. The significance of the change will dictate the type of reporting required for both 510(k) cleared devices and PMA approved devices.
  • Your quality system should include a CAPA (corrective and preventive action) tracking system to record and address any issues that arise after the device is on the market.

For additional information on FDA submission processes, see our ebooks which cover the 510(k), and De Novo processes.

Featured

Rimsys Announces Rimsys AI to Eliminate Repetitive Tasks and Enhance Decision-Making for MedTech Regulatory Teams

Rimsys, the leading Regulatory Information Management (RIM) platform for the MedTech industry, today announced the launch of Rimsys AI, a suite of embedded artificial intelligence (AI) agents.

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MedTech

Nonconformance reporting for medical device manufacturers

By

Wendy Levine

March 30, 2023

4 min read

Defining nonconformance

Very simply, a nonconformance occurs when a specification is not met. The FDA defines a specification in 21 CFR 820.3 as “any requirement with which a product, process, service, or other activity must conform,” and ISO 13485:2016 as a “need or expectation that is stated, generally implied, or obligatory.”

While managing nonconformance starts with fully defining specifications; it is the identification, tracking, and resolution of nonconformance that is a focus of medtech quality and regulatory teams and a requirement of both ISO 13485:2016 and the FDA’s 21 CFR Part 820 quality system regulation.  

Identifying nonconformance occurrences

As part of a compliant quality system, medical device manufacturers should implement procedures to identify and address both major and minor non-conformances. Nonconformances may be identified through processes found in multiple subsystems that are part of an overall quality management system within the organization.

The systems and subsystems in which nonconformances are identified typically include:

  • ERP
  • Regulatory information management (RIM)
  • Product lifecycle management (PLM)
  • Document management
  • Customer service / customer management  
  • Complaint handling
  • Device history records
  • Audit management
  • CAPA
  • Training/learning management  
  • Calibration/preventative maintenance
  • Development change management

Evaluating nonconformance

Once a nonconformance is identified, it should be evaluated in a timely manner, and a determination made as to the disposition of any affected products. Requirements for additional investigation and reporting should also be identified. Based on the severity of the nonconformance and its effect on the safety and efficacy of devices being manufactured or already in the market, a CAPA (corrective/preventative action) record may need to be created. In the U.S., this is defined in the quality regulation 21 CFR Part 820.100.

To disposition a nonconformance, consider the following:

  • Will the existing system detect the nonconformance if it recurs in time for remediation?
  • How likely is it that this issue will recur?
  • What is the impact of the non-conformance (i.e., could it affect patient health)?

Issues that are more severe or are more likely to recur should trigger a more immediate and comprehensive response.

Nonconformances that are escalated and handled under CAPA are based on risk and can include those that have or could have an impact on a product or process that is:

  • Not easily corrected
  • Recurring
  • Severe

In addition, nonconformances that rise to the level of a CAPA require significant resources and typically result in a full project to identify root cause(s), containment, and corrective actions, and monitoring for effectiveness.  

Nonconformances that don’t require a CAPA have simpler resolutions that include documenting actions taken to correct the issue (or justification for no action). If the issue is not recurring, there may be no other action required. For example, a nonconforming material received from a vendor may be a singular issue that was easily identified through existing inspection procedures and is not expected to recur. In this case, the material is returned to the vendor and no additional action is required.

Processes that are out of conformance are often resolved through improved documentation and/or additional user training. However, be sure that the true root cause of the nonconformance is identified as procedural nonconformances can signal additional issues.

Documenting nonconformances

An important part of nonconformance procedures is the nonconformance report (NCR) or other documentation procedures.  Nonconformances are typically documented within the subsystem in which they were identified. Some organizations will have a nonconforming system in which issues originating from all subsystems are documented. Centralized nonconformance systems allow for trending and other analysis across all subsystems, the results of which may generate CAPAs.  

The requirements for documenting a nonconformance may vary by subsystem. In general, however, nonconformance documentation records:

  • The requirement/specification that was not met.
  • The objective evidence supporting the determination.
  • The action that is being taken to address the nonconformity.

Nonconformances are a common point of focus during quality audits by regulatory bodies, including the FDA, and should follow a well-documented process. Auditors will often try to determine if the quality system is functioning effectively by looking at self-identified nonconformances and comparing them to externally reported nonconformances. This is to ensure that nonconforming products were not released, or that the appropriate actions were taken to resolve issues in the field.

The importance of nonconformance reports

Nonconformances related to distributed products of higher risk result in nonconformance reports issued to government authorities through vigilance reporting, medical device reporting, and field action/recall reports. For example, the FDA requires that a medical device report be submitted within 30 days of a serious adverse event (see 21 CFR Part 803 Subpart E). Strong reporting procedures for nonconformances of all types are important in identifying trends, addressing issues before they become critical, and as part of a complete quality management system.

A nonconformance reporting procedure is only part of a strong quality system. Read An overview of 21 CFR part 820 and ISO 13485 overview for more information on establishing quality systems for medtech companies.

‍

Company

Why we developed Rimsys from the ground up

By

Wendy Levine

May 26, 2022

4 min read

Rimsys has had quite a year already! In early December, we closed on $16 million in Series A financing and since then we have been carefully growing the company to better serve our customers and the regulatory affairs community. We have almost doubled our employee count and redesigned the Rimsys system to deliver deeper functionality that is even easier to use. We had our first in-person employee meeting here in Pittsburgh at the end of April where we introduced our new mission statement, and we are all excited to be doing our part to improve global health!

All of these changes made us think back to the founding of Rimsys and how far we have come. So - I sat down with Rimsys Founder and CEO, James Gianoutsos, to talk about the genesis of the company and how he knew that a new type of system designed for medtech regulatory affairs professionals was needed, and needed to be built from the ground up.

Q: What was the biggest challenge you faced as a regulatory professional that led you to form Rimsys?

James: The biggest challenge I saw while working at Philips for many years was completely understanding the complexity and the nuances around everything regulatory from a product standpoint. This really came to light whenever we acquired products. Just seeing firsthand how inefficient and out of compliance these manufacturers really were, and how hard it was from an administrative standpoint just to get into compliance and then to stay compliant, was striking. 

I was working with a smaller medical device company which had acquired products from Philips. Philips provided the company with a list (a color-coded Excel spreadsheet)  of all of their products that the company had acquired along with the registration status of those products globally. After digging into the spreadsheet for several months, we found that about 50% of it was wrong, incomplete, or just completely missing. The company was trying to keep track of registration information, but the available tools were making it nearly impossible. I realized that this was the challenge, and that there really wasn’t a solution on the market that could solve that problem in an easy manner and in a medtech regulatory-focused way.

‍Q: There were solutions on the market that were geared more towards the pharmaceutical industry, correct?

‍James: Yes. So I did what every other regulatory professional did, which was to Google “regulatory software,” and I saw that there just really wasn’t anything on the market that fit our needs. The solutions on the market really were pharma-specific, even those that said they worked with medical devices. The workflows and regulatory requirements for medtech are very specific for each market, depending on the product type and risk class and so many other factors. To use a pharma system that was already on the market  just wasn’t even an option because it was like comparing apples to oranges. It is completely different from the regulatory and workflow side of things.

‍Q: There are existing tools used by the regulatory community, such as quality management and document management systems. Did you envision the new RIM system integrating with existing tools, replacing them, or a little of both?  

‍James: I never set out to replace those types of systems, no. In fact, I knew that existing system architecture and infrastructure couldn’t handle the specific medtech regulatory workflows but needed to connect to those systems. There have always been PLM (Product Lifecycle Management) systems that contain a company’s product master data, but those systems were never meant to be workflow-driven based on regulatory requirements. At the same time, they are critical for organizing and maintaining product-specific metadata. Then there are ERP systems, which are really about making sure companies have sales flags (i.e. regulatory blocks) in place, appropriate shipping codes, or selling status linked to product registration status. Regulatory professionals are concerned about answering two questions for ERP users; one, “does the product have a valid and current registration within the country or market,” and two, “if it is registered, are we selling and shipping into that market.”  Lastly, quality/document management systems house critical documentation and records needed for registrations. The problem with these systems is that there are no regulatory workflows and no way to compile technical documentation, leaving the documents and records siloed from the regulatory filings.

To do the things that a regulatory affairs professional, in a critical regulatory department, does for their company, the system really had to be built from the ground up with all of these systems in mind. It had to be product-centric. It had to integrate with all these other sources of information, because there really wasn’t a common connection point between your products, your documentation, and the records that you needed to compile and how that relates to getting products on the market. We had no way to communicate to our other systems that a product is actually available for sale in that market or that it confidently can, or more importantly cannot, ship to that market.

‍Q: What was the most difficult piece of functionality to implement in Rimsys?  

James: Well, at the time it kind of all seemed difficult! No, really the most difficult part was thinking thoughtfully and strategically about how data was going to be mapped and used in conjunction with other data elements, in order to make the system most helpful from a user perspective. We wanted to single-source information to enhance and streamline regulatory workflows, but then also make sure that it was as user friendly as possible. There are a lot of stakeholders that need information or have input into regulatory workflows. Quality assurance, marketing operations, R&D, engineering, sales - all of those specific stakeholders need to view information in a way that is understandable to them.

We worked hard to bring all that information, streamline complex regulatory workflows, and all of those internal and external data sources together in an understandable and user-friendly way.

Q: How important has the technology itself been in the creation of Rimsys?

James: Technology has been a huge advantage for us from day one. Our team had quality and regulatory backgrounds, so we knew what companies would expect from us. We knew we had to be 21 CFR Part 11 compliant. We knew we had to be ISO 27001 certified. We knew we had to have SOC2 Type 2 reports. We knew we had to integrate with a company’s existing IT infrastructure. We really had to build this thing from the ground up on a GxP compliant platform that we could build upon and expand, without having to go back and reinvent the wheel every time we added new functionality. 

It’s continued to pay dividends for us because it was something that we thought about from the beginning and that gave us a lot of flexibility. We already had the system and infrastructure in place that we could then expand upon a lot more quickly than we would have been able to otherwise. It’s like the difference between building a house today and trying to remodel a house that was built in the year 1900. If you break down a wall in the older house, there might be so many hidden issues behind that wall - load bearing issues, knob and tube wiring, asbestos, etc. With new modern infrastructure, it is just night and day in terms of adapting quickly with changing regulations and a fast-paced market.

Q: Was there any specific technology you can talk about that became important to the development of Rimsys?

James: Our choice of technology was driven by our desire to build a system that was user friendly and built on a modern infrastructure that felt familiar to our users. So, we took a lot of the Google framework to build an application that didn’t look like enterprise software, but looked and felt more like a consumer product that is inviting, not overwhelming. 

The other thing is that we built the system from day one to integrate because we knew we had to connect with a lot of different sources of information. We strategically built the system with API’s in mind.

Q: What is Rimsys doing differently than other software companies in the regulatory space?

James: We are creating a holistic solution, which is different from what is out there now. We know that registration management is just one key aspect of what regulatory affairs teams need. In order to create a proper regulatory system, we had to take into account all of the data and dependencies and build a system specifically for medtech regulatory teams and other key consumers of regulatory data. There has to be a single source of truth for this data, because otherwise it becomes a nightmare at the end of the day. Existing software solutions were siloed and purpose-built for other industry needs, such as eQMS, PLM and ERP. None of those systems can do what a holistic RIM platform can do. Because of the complex workflows, the regulatory needs are far too broad and interdependent, that data infrastructure is completely different, data sources are too numerous, and the systems offer limited support to bring everyone and everything together into a cohesive, streamlined, compliant and medtech-specific solution.

Another key component of what we are doing is to institutionalize regulatory knowledge and resources into Rimsys—this is at the heart of who we are and what we do. Having the only purpose-built, holistic RIM platform built by and for regulatory professionals specific for the medtech industry really couldn’t be done without internalizing that experience within our own team.

Q: What are you most proud of when it comes to Rimsys? 

James: I think there are two things that immediately come to mind. Having our Rimsys 5 platform launch is really exciting. This is the fifth iteration of our platform, and we did it by listening to our customers and iterating over and over again to get it right. We had to go back to the drawing board a couple of times, not because what we had written wasn’t working, but because our customers that were using the system every day gave us better ways to do things. Rimsys 5 is a really proud moment because this is the platform that we are taking into the future, that will let us get to the next level where we are truly empowering regulatory professionals to make critical decisions and do the job that they are meant to do. 

The ability for us to listen to our customers, take that feedback and move fast is the second thing I’d mention here. We know that this has to be a validated system, but we are able to make changes and add features in a way that is thoughtful and gets our customers what they need right away. Regulatory professionals are very particular. I know since I am one, and making sure they are comfortable using Rimsys from day 1 is critically important. Being a customer-centric company really makes our experience as a team extremely rewarding.

Q: Where is Rimsys going next?  What are you most excited about?

I think I am most excited about Rimsys being an advocate for the medtech regulatory community and helping them wherever we can. Regulatory has a seat at the table now and it is a great feeling to see that we’re able to help these companies to streamline their workflows, accelerate time to delivery for life-saving products and maintain that compliance to keep those products on the market. Regulatory affairs is a mission critical department that the medtech industry cannot underestimate. It’s empowering because while we are helping our customers, they are helping us and every single one of our other customers through the journey of regulatory uncertainty that everyone is going through right now. It feels like a real partnership between us, our customers, and the industry as a whole and I am excited to see where that will take us.

I am also really excited about where we are going with regulatory intelligence. We are just scratching the surface of this now, but you will see regulatory intelligence data built into Rimsys and providing RA professionals with tools that can really provide a competitive advantage for their company. The release of Rimsys 5 platform (“Phase 1”) provides us that platform that will take us into “Phase 2” of Rimsys, with embedded intelligence that will further empower regulatory professionals to make decisive, correct and confident decisions for their products and their company.

MedTech

Your eSTAR submission questions answered by FDA experts

By

Bruce McKean

September 8, 2023

4 min read

Your eSTAR submission questions answered

Starting on October 1, 2023, all 510(k) submissions, unless exempted, will need to be submitted electronically using eSTAR. eSTAR, which is short for Electronic Submission Template and Resource, is a dynamic PDF submission template that contains automation, guides, integrated databases, integrated policies and procedures, and automatic verification to help users prepare a comprehensive medical device submission.

Rimsys recently hosted a webinar, eSTAR submissions overview and live Q&A with FDA, to help the medtech community prepare for the quickly approaching eSTAR deadline. Patrick Axtell, Assistant Director for Tools and Templates Team, and Sajjad Syed, Software Engineer for Tools and Templates Team, from FDA joined our panel of Rimsys regulatory experts to provide an overview of eSTAR, demo, and live question and answer session. If you're interested in watching the webinar replay, you can find it here.

Due to high participation, we couldn't answer all questions live. This blog post provides Patrick's and Sajjad's answers to questions we couldn't get to during the webinar. Read below to learn what other industry professionals want to know about eSTAR!

Q: In the past, the sections were numbered Section 10 - Device Description.  How should section(s) be numbered in the eSTAR?

You may number attachments how you prefer, this includes numbering attachments according to the previous section numbers of the Format for Traditional and Abbreviated guidance document.  However, the numbering hierarchy in the IMDRF documents, which the attachment questions in eSTAR correlate to, may be better, since that numbering scheme is internationally harmonized.  So for example, if you are using the nIVD eSTAR, the IMDRF document specifies the Comprehensive Device Description would be numbered 2.04.01: https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-190321-nivd-dma-toc-n9.pdf.

Q: After October 1, 2023, will the In Vitro Diagnostics eSTAR Version be acceptable to use for a Dual 510(k) and CLIA Waiver by Application (Dual Submission)?

Yes, the next IVD eSTAR update will fully support Dual submissions, and the workaround we were previously implementing will no longer be needed. CLIA waiver submissions will continue to be submitted via current methods, and are not required to use eSTAR after Oct 1, 2023.

Q. It is not possible to view eSTAR online from cloud storage platforms. eSTAR like IFU Form and CDRH Form cannot be viewed online without users downloading these files. I will highly appreciate if  someone from the panel can give a solution to this. I understand these are special pre-programmed PDFs but it will immensely help if these can be shared for online viewing without having users download these files.

You need to choose to open eSTAR in the default application from within the cloud application you use, you can’t just click on it, since it will open in the browser, and browsers can’t open dynamic PDFs like eSTAR, Form 3881, Form 3514, and other forms FDA uses.

We can’t say that all cloud applications will work, but using Box does work. Once eSTAR is loaded in, click on the three dots, then choose the application you have installed, see screenshots below. I have Adobe Acrobat 2017 and Adobe Acrobat Pro both installed.

Be aware that every time you save the form, you upload it back into the cloud, so depending on how large it is and how fast your internet connection is, it may take many seconds to save each time, though you will see a progress bar.

Q: Does the eSTAR submission need to be submitted by only the US Agent or can this be done by the Foreign Manufacturer?

510(k) eSTARs, like 510(k) eCopies, can be submitted by foreign applicants.

Q: Will it be mandatory to use the eStar template for PMA supplement submissions?

Yes, by the end of 2023, eSTAR for PMA will be released. Similar to eSTAR for 510(k), there will be a pilot, guidance, and a transition period before it becomes mandatory.

Q: When do you expect to release the next version or sub-version of the non-IVD eSTAR template (4.x or 5.0) and will it be more elaborate on cybersecurity?

We are at the mercy of updating when policies are updated, which is irregular and unpredictable. Please email CDRH management and recommend a more consistent (e.g. quarterly) policy deployment schedule so that eSTAR can also have a more predictable deployment schedule. We are updating approximately one to every two months currently. Please be sure to read the Version History on page 1 of eSTAR regarding versioning and which version to use.

Q: How should a device categorized as a breathing gas pathway device in accordance with ISO 18562 be handled in eSTAR? One cannot find ISO 18562 categorization for a device in the eSTAR form.

This is a regulatory and policy question, and we are not sure what is meant by the statement “be handled.” Please reach out to OPEQ Submission Support OPEQSubmissionSupport@fda.hhs.gov with this question and they will direct your question appropriately.

Q: How often does FDA anticipate revising the eSTAR form?

eSTAR updates are almost exclusively timed according to policy updates, which the Tools and Templates Team has no control over. The T&T Team, as well as other groups in CDRH, are pushing for a quarterly update, where any policy updates in a quarter have an implementation date set for the beginning of the next quarter (e.g. Oct 1st, Jan 1st, Apr 1st). Please email Center management and promote this.

Q: The guidance Format for Traditional and Abbreviated 510(k)s: Guidance for Industry and FDA staff recommends a specific format for submissions. Biocompatibility, for example, is section 15. Should attachments in the eSTAR submission cross-reference the sections cited in the guidance? (So still using biocompatibility as an example, attachment 15.1 would be Cytotoxicity, attachment 15.2 would be Sensitization and so on)

The Format guidance, as well as the eCopy guidance, RTA guidance, and many other guidances, no longer apply for eSTARs.  Eliminating the applicability of guidances - simplifying the preparation process - is something we are proud of doing. You do not need to follow the numbering of this guidance.  See response above, where we recommend using the IMDRF numbering scheme instead, which is internationally harmonized.

Q: Where is information for risk assessments and management best included?

Depending on the type of submission you have selected (e.g. 510(k), De Novo, then Traditional, Special, Abbreviated), certain sections will become visible and active and some of them will be disabled. However, the bookmark pane will show all the sections in the entire eSTAR. Hence, please fill the sections that are visible to you since they are based on your selections. For example, if you have selected a Traditional 510k, the “Benefits, Risks and Mitigation Measures” section is not applicable. Hence it is not displayed and clicking on it leads a user back to the first page of the eSTAR. However, if you select “Special” as the 510k you are submitting, the “Benefits, Risks and Mitigation Measures” section does become applicable, and is displayed if you click on the bookmark. Also note that if you select De Novo, the section does become active as well. Another point to note is that for a Traditional 510(k) submission, if you do want to submit a Risks, Mitigations, Benefits report, you can attach it in the Performance Testing --> Bench Testing section of the eSTAR and identify it as “Other Non-Clinical Evidence”.

Q: Under Biocompatibility any idea when there will be endpoint questions for hemocompatibility or coagulation?

Hemocompatibility endpoint information, including Hemolysis, Complement Activation, and Thrombogenicity information, will appear depending on the tissue contact type and duration you choose. If you choose Implant Device >30 days, you will see this tab appear for example. The tabs that show are based on our Biocompatibility guidance.

Q: Guidance and Special Controls Adherence Section: According to the 510(k) electronic submission guidance document, identification of any applicable device-specific guidance documents or special controls should be included, which was done in the past; however, eSTAR requires each specific special control regulation or guidance recommendation to be listed. Can you please specify to what level of detail needs to be included within this section? The text box contains a character limitation, so it is unclear how specific information needs to be.

There are four textboxes like this in eSTAR. The specifications, characteristics, etc., of the device should not be provided in these textboxes. Instead, these textboxes should be used to refer to the attachments where these controls or recommendations are found, per each specific recommendation. These textboxes do expand as text is typed in, if needed. Keep in mind that the special controls, device-specific guidance citations would be divided among these four textboxes.

Q: Why are Advertisements included within the Labeling section, when they should be considered promotional materials? Could reference to advertisements be removed from this section?

Advertisements and promotional materials are included under the Other Labeling, and within the sub-attachment type "Other Labeling and promotional material" since this is consistent with Internationally harmonized document N9 and N13.  As the help text states, whether you actually need to attach it at all (it is an optional attachment) is dependent on the jurisdiction. For FDA, you would need to reach out regarding your device and current policy at opeqsubmissionsupport@fda.hhs.gov.

Q: I need to know how eSTAR would promote efficiency.

There are many efficiency gains with eSTAR, this is not an exhaustive list. The eSTAR website also includes some of this information.

-eSTAR complements the reviewer's internal smart review template used to review the submission (i.e. the questions correlate).  Therefore the reviewer is getting what they are expecting

-eSTAR provides a standardized format so that the reviewer (and applicant) always know where to find certain information

-eSTAR auto-updates many aspects of the submission, most notably it ensures the content is present negating the need for an RTA review by the reviewer, and therefore RTA holds

-eSTAR autocompletes information that you enter, ensuring you never need to enter the same information twice

-eSTAR includes built-in databases that ensure you see the information pertinent to your device (e.g. device-specific guidances), classification information automation, and the standards database, for auto-filling standards info accurately

-eSTAR has many forms built in, so that you don’t need to attach or upload them (e.g. T&A statement, Form 3514, 510(k) Summary, Declaration of Conformity, Form 3881)

-eSTAR guides the applicant through what is needed throughout, ensuring we collect everything that needs to be provided, and you know how to do it correctly

-eSTAR is collecting submission data in a structured format, which will help automate many aspects of our processing.  This will provide applicants and reviewers many benefits (e.g. automating the submission log-in process, therefore permitting reviewers to receive a submission within minutes of when the submission is uploaded in the CDRH Portal)

-eSTAR is intended to be used as a resource also, since it consolidates all the information needed (e.g., regulation links, guidance links, submission process information) to prepare a submission
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