Refuse to Accept Policy and the Future of FDA Submissions

RAQA Café

A podcast series that tackles trending Regulatory Affairs and Quality Affairs (RAQA) topics within the MedTech industry.

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What is the FDA’s Refuse to Accept Policy? In this second episode of NAMSA’s RAQA Café Podcast, we are joined by NAMSA’s Principal Product Development Strategist, Angela Mallery, to examine the procedures and criteria the FDA use in assessing whether a premarket notification 510(k) submission meets a minimum threshold of acceptability, and if it should be accepted for substantive review. Also discussed during this podcast is FDA’s voluntary eSTAR (electronic Submission Template and Resource) program, which aligns with FDA’s internal review template and integration of guidance expectations.

“When you are doing your 510(k), you should set up your expectations with management far, far ahead so they don’t have the expectation that 90 days later they are going to be able to sell the product.  Setting these expectations is one of the things the regulatory person should do… The whole process generally takes four to six months.” – Angela Mallery

Discussion topics include:

• FDA Refusal to Accept (RTA) screening process 510k submissions
• RTA Checklist (Traditional 510k, Abbreviated 510k, Special 510k)
• FDA eSTAR Program, a voluntary electronic submission template

*Please note that the opinions discussed throughout the podcast are their own and do not reflect that of their current or former employers.