Often, the first thing we hear from a consultant or a medical device company regarding an FDA 510(k) premarket notification is that it was delayed because the FDA reviewer did not understand something simple within the application, or completely missed it.

What is wrong with the reviewer?  How could they have missed something so simple?  I couldn’t have been any clearer!

Sound familiar?

FDA is overworked, under-resourced, and will most likely miss something simple in your file upon reviewing.

As the specification developer, you know the design and history of the product better than anyone.  You are providing that entire history in a formal application for review, and hopefully, clearance.  A basic understanding of the technology is a must; however, think about the situation from the FDA reviewers’ point of view.  510(k) applications are inherently technical and sometimes need a brief discussion with the FDA reviewer for clarification or a general overview of your device.

Starting this dialog earlier is important for a smooth path to clearance.  Part of this process involves requesting a Pre-Submission (“Pre-Sub”).  Pre-Subs are a type of feedback that is part of FDA’s Q-Submission program.


Pre-Subs are a formal written request from an applicant for feedback from FDA to be provided in the form of a formal written response or a meeting (in-person or teleconference) in which the feedback is documented in meeting minutes.  A Pre-Sub provides the opportunity for a submitter to obtain FDA feedback prior to intended submission of a premarket submission (i.e., IDE, PMA, HDE, De Novo request, 510(k), Dual, BLA, IND) or Accessory Classification Request, among others.

Pre-Subs are entirely voluntary on the part of the applicant. However, early interaction with FDA and careful consideration of FDA’s feedback may improve the quality of subsequent submissions, shorten total review times, and facilitate the development process for new devices.

Pre-Subs provide FDA reviewers with an introduction to you and your device rather than just having a 510(k) application dumped on their desk.  FDA reviewers appreciate Pre-subs because they can get a sense of when they should anticipate filings and can plan their workloads accordingly.

FDA reviewers, like all of us, only have a certain amount of time during the day.  If they are unable to find information easily or do not properly understand something, then they may state that the relevant information is missing from the application or needs further clarification.  This kicks the 510(k) application back to you and stops the review clock. That is directly on the industry submitter, not the FDA reviewer.

The Bottom Line

FDA reviewers are people too.  This is an obvious but often overlooked point to make.  Sometimes they miss simple (and sometimes seemingly apparent) information.  They make mistakes.  The last thing you want to do is start yelling or pointing fingers.  After all, you don’t want to burn any bridges as you will most likely deal with the same FDA reviewer upon subsequent submissions for similar products.  Always be timely, concise, straightforward and respectful.

At the end of the day, keep in mind that your FDA reviewer isn’t as familiar with your medical device as you are.  You need to help them understand items that are unclear, and the only way to do that is through building the communication channel early and having constructive conversations.

Did you know RIMSYS Regulatory Management Software will keep track of all communications, notes, decisions, and tasks associated with your 510(k) application and other international regulatory submissions?  Find out more now with a free demo and we will show you the power of the only regulatory information management (RIM) system platform designed specifically for the medical device industry.

This article, in collaboration with Right Submission, is part of a regulatory insight content series catered specifically to the medical device industry. RIMSYS and Right Submission, leading medical device regulatory software solution providers, have teamed up to provide decades of regulatory expertise and behind-the-scenes knowledge to its current and future customer base which includes thousands of regulatory affairs professionals.

About Right Submission:

Right Submission enables medical device regulatory professionals to create higher quality content by bringing automation, project management, and collaboration to regulatory submission creation and publishing.



RIMSYS is a Regulatory Information Management (RIM) platform designed specifically for the medical device industry.  RIMSYS offers a suite of cloud-based regulatory affairs software solutions to simplify and manage global product registrations, standards, essential principles requirements, regulatory documents, changing regulations and more.


What is the Medical Device Single Audit Program (MDSAP)?

The International Medical Device Regulators Forum (IMDRF) recognized that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale.  This created the Medical Device Single Audit Program (MDSAP) and allows a recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

To date, the MDSAP participating countries include:

The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) are Official Observers, which means they are waiting for the results of the pilot MDSAP program to determine if it’s worth their while to sign on as an official partner.

When does MDSAP come into effect?

Starting January 1, 2019, if you’re selling medical devices into Canada, it’s not optional and you must be certified to MDSAP, or at the very least, show evidence that you are in the process of complying.

As part of the MDSAP auditing program, there are seven chapters an auditor must cover.  One of those chapters is specific to marketing authorization and facility registration, which also touches on two other chapters, management and design development.  An auditor will be specifically looking for the following:

  1. Have you complied with requirements to register and/or license your device facility;
  2. Did you submit device listing information;
  3. Did you obtain device marketing authorization;
  4. Have you arranged for assessment of changes and obtained marketing authorization for changes to devices or the quality management system which require an amendment to existing marketing authorization

You must have that information organized in a meaningful way that you can get to it quickly and show, objectively, that you fulfilled the requirements of MDSAP and all of the country regulatory requirements that fall under MDSAP.  That also goes hand-in-hand with ISO 13485:2016 where you need a controlled release of products into the appropriate jurisdiction.  If you’re trying to be a global leader or a global company, for that matter, in this day and age, you need to have a solid system in place to manage those marketing authorizations worldwide.

Controlled Release of Product

If you are selling out of the United States, you must comply with the laws of each importing country.  That simply means, no matter where you sell outside of the United States, you must meet the importing country’s requirements for marketing authorization. Your regulatory team and business need to be on point by having a robust regulatory system in place that upon product release, you’re meeting those specific requirements.  You must have a mechanism in place to ensure that you don’t release product prior to it being properly registered.

That mechanism starts during product realization.  Sales, marketing, customer service, engineering, operations, and regulatory teams must all be on the same page.  Often times, regulatory is perceived as the bottleneck to product release.  However, this is a misconception and is primarily driven by poor planning during the design and development process.

Auditing to MDSAP

Auditors are looking for the standardized process for controlling the release of the product and ensuring that the process has been adequately established and implemented within your facility.  MDSAP has a very rigid auditing process to ensure the proper market authorizations have been obtained and facility registrations have occurred.

When your company is audited, an auditor will request records from product outside of the MDSAP participating countries due to the broad jurisdiction of US and international regulations.  If the auditor finds issues with those products, they can draw that parallel to determine that your company doesn’t have a controlled product release process and you need to investigate to ensure there isn’t a systemic issue.  That means an audit observation and a corrective and preventive action (CAPA) plan need to be established to rectify the issue(s).

What does this mean for medical device manufacturers?

A regulatory professional’s job is worldwide nowadays, which means it is a lot of responsibility, burden and business risk that are on their shoulders.  Do you really want all of that being managed by excel files, outlook reminders, and disjointed processes?  It must be a fundamental, standardized process, ingrained into your quality management system, that you need in place in order to NOT run into any compliance issues.  Your organization must have a standardized process to ensure that your company is releasing good (and approved) product into the market while maintaining any changes to that product (and registration) while it’s in that market.

The requirement is not only that you get the marketing authorization, but you stay compliant when you’re already in that market. That means you must constantly be monitoring for expiring registrations, any type of design changes with your product, and how they affect your marketing authorizations within those countries.

From a quality management system standpoint, you need a good change control process in place that ties directly to your regulatory team. If you don’t have a good regulatory process now, you’re not going to have one later. It’s going to be too late, and the amount of information that your regulatory team must handle today is only going to increase. That’s why you must develop those systems now.


I had the opportunity to sit down with Jon Speer, Founder & VP of QA/RA at Greenlight Guru to record a podcast to discuss streamlining the MDSAP Marketing Authorization & Facility Registration Process.
If you are not familiar with this topic, you need to hear this.
We discuss:
  • Why your regulatory team may be perceived as a bottleneck and why it is important everyone needs to be on the same page about when the product can be released.
  • The connection between marketing authorization and facility registration required for various countries – United States, European Union, or elsewhere.
  • The need to get organized, get better systems in place, and stay compliant when an auditor comes through your door or when you plan to sell into markets.
  • Why small and large companies need to get organized now (i.e. small companies have too much information to maintain, organize, and track while large companies may have resources but suffer from miscommunication and disjointed processes.)
  • The need to not be complacent and not be afraid to change systems. RIMSYS was created to help regulatory professionals successfully and efficiently handle documentation.
You can hear the podcast below or at the Greenlight Guru blog.

RIMSYS’ own James Gianoutsos recently contributed an article on www.meddeviceonline.com discussing FDA’s guidance document describing accessories and classification pathways.

The guidance explains which devices FDA generally considers “accessories” and describes the processes under Section 513(f)(6) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow requests for risk- and regulatory control-based classification of accessories. In other words, it specifically details what is and is not an accessory, as well as the regulatory routes to classification.