After three “Refusals To Accept” Guidance Documents from the FDA, why are there still so many submission issues? Who’s to blame? Learn from other people’s mistakes.  

In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mike Drues of Vascular Sciences about the FDA’s Refusal to Accept (RTA) policy and guidance. 

Some of the highlights of this episode include:

• After the FDA receives a 510(k), De Novo, Pre-Market Approval (PMA), or any other submission, the 2-step process is to conduct an administrative and then a substantive/scientific review.
• If a submission is rejected on the administrative review, it is completely the company’s fault, not the FDA’s. If the substantive review is rejected, however, there’s room for negotiation with the FDA.
• Most of the FDA’s acceptance checklists have been available for more than a decade, but companies submissions are still commonly rejected on administrative review.
• Electronic tools and software platforms, such as eSTAR, are supposed to help and facilitate the preparation process of submissions. The problem is, this is contingent on what information is entered.
• Potential hangups for companies using tools like eSTAR for the submission process are that they do not evaluate the quality of the content entered. That said, they do require a Table of Contents and the use of most current forms.
• Never leave any sections of your submission blank. At the very least, enter Not Applicable (N/A) and explain why - or risk the FDA rejecting the submission. It’s a company’s responsibility to make sure the FDA understands their device.
• The draft guidance documents have been published for a reason - don’t ignore them and risk a rejection for what could easily have been avoided. 

Memorable quotes from this episode:

“If a submission gets rejected on an administrative review, that is 100% the company’s fault, it is not FDA’s fault.” Mike Drues

“Approximately 60% of 510(k)s are rejected on RTA part of the administrative review.” Mike Drues

“An eTool should help facilitate the process. However, caveat—it still is contingent on humans entering information.” Jon Speer

“I would like the FDA to be just as careful with the claims that they put on their own website as they are when they are evaluating claims on a device coming in for a submission.” Mike Drues

“One of the most common reasons why submissions are rejected is because a particular section is left out. Put yourself in the shoes of the reviewer. They have no idea why you are leaving out that section.” Mike Drues

Links:

How To Avoid Having Your FDA Submission Rejected (And What To Do If It Is)

Guidance: Refuse to Accept (RTA) Policy for 510(k)s

Guidance: Acceptance Review for De Novo Classification Requests

Guidance: Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)

Acceptance Checklists for 510(k)s

Medical Device User Fee Amendments (MDUFA)

FDA - Voluntary eSTAR Program

What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?

Mike Drues on LinkedIn

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru Academy

Greenlight Guru Community

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