This is a podcast episode titled, Examining FDA’s Refusal to Accept (RTA) Policy and Guidance. The summary for this episode is: <p>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.&nbsp;&nbsp;</p><p>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.&nbsp;</p><h3>Some of the highlights of this episode include:</h3><ul><li>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.</li><li>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.</li><li>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.</li><li>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.</li><li>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.</li><li>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.</li><li>The draft guidance documents have been published for a reason - don’t ignore them and risk a rejection for what could easily have been avoided.&nbsp;</li></ul><h3>Memorable quotes from this episode:</h3><p><em>“If a submission gets rejected on an administrative review, that is 100% the company’s fault, it is not FDA’s fault.” Mike Drues</em></p><p><em>“Approximately 60% of 510(k)s are rejected on RTA part of the administrative review.” Mike Drues</em></p><p><em>“An eTool should help facilitate the process. However, caveat—it still is contingent on humans entering information.” Jon Speer</em></p><p><em>“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</em></p><p><em>“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</em></p><h3>Links:</h3><p><a href="https://www.meddeviceonline.com/doc/how-to-avoid-having-your-fda-submission-rejected-and-what-to-do-if-it-is-0001" rel="noopener noreferrer" target="_blank">How To Avoid Having Your FDA Submission Rejected (And What To Do If It Is)</a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks" rel="noopener noreferrer" target="_blank">Guidance: Refuse to Accept (RTA) Policy for 510(k)s</a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-review-de-novo-classification-requests" rel="noopener noreferrer" target="_blank">Guidance: Acceptance Review for De Novo Classification Requests</a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-and-filing-reviews-premarket-approval-applications-pmas" rel="noopener noreferrer" target="_blank">Guidance: Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)</a></p><p><a href="https://www.fda.gov/medical-devices/premarket-notification-510k/acceptance-checklists-510ks" rel="noopener noreferrer" target="_blank">Acceptance Checklists for 510(k)s</a></p><p><a href="https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v" rel="noopener noreferrer" target="_blank">Medical Device User Fee Amendments (MDUFA)</a></p><p><a href="https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program" rel="noopener noreferrer" target="_blank">FDA - Voluntary eSTAR Program</a></p><p><a href="https://www.greenlight.guru/blog/what-is-estar-pilot-program-and-how-will-it-improve-fda-510k-review-process" rel="noopener noreferrer" target="_blank">What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?</a></p><p><a href="https://www.linkedin.com/in/michaeldrues" rel="noopener noreferrer" target="_blank">Mike Drues on LinkedIn</a></p><p><a href="https://www.youtube.com/channel/UCYfQsPqHW8H8mZ4xpM4gn1Q" rel="noopener noreferrer" target="_blank">Greenlight Guru YouTube Channel</a></p><p><a href="https://www.greenlight.guru/podcast-mtqs" rel="noopener noreferrer" target="_blank">MedTech True Quality Stories Podcast</a></p><p><a href="https://www.greenlight.guru/academy" rel="noopener noreferrer" target="_blank">Greenlight Guru Academy</a></p><p><a href="https://www.greenlight.guru/medical-device-community" rel="noopener noreferrer" target="_blank">Greenlight Guru Community</a></p><p><a href="https://www.greenlight.guru/" rel="noopener noreferrer" target="_blank">Greenlight Guru</a></p>