Refuse to Accept Policy and the Future of FDA Submissions

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.

Meet the Speakers

Angela Mallery, EdD; Former Principal Product Development Strategist, NAMSA

Angela has worked within the medical device industry for over 30 years for companies such as Zimmer, Ev3 and St. Jude Medical before she turned to consultancy. At NAMSA, Angela works with innovative medical device companies to assist them in the development and implementation of regional and global regulatory strategies. This experience encompasses writing and implementing successful Breakthrough and Safer Technologies Program (STeP) submissions, a passion for pre-submissions and an interactive approach to working with FDA. She has a depth of experience with 510(k)s, Investigational Device Exemption (IDE), Premarket (PMA), De Novo and Humanitarian Device Exemption (HDE) submissions.

Linford Leitch; Former Regulatory Consultant, NAMSA

In 2021, Linford joined NAMSA as a Regulatory Consultant. He has 9 years of experience in the medical device industry with direct regulatory experience with Spine, Transcatheter Heart Valves and Hemodialysis devices. He specializes in developing global regulatory strategies for entry to market and maintain strategies throughout product lifecycle.

Richard Granquist; Senior Quality System Consultant, NAMSA

Rich Granquist has 17 years of experience in the medical device industry and has spent extensive time working with both start-up manufacturers and larger, global device manufacturers. He specializes in quality system development and risk management.

Rich started in the medical device industry as a Microbiologist focusing on preclinical testing including, packaging validation, biocompatibility testing and reprocessing instruction validation for urology and women’s health devices. He spent several years as a Quality Engineer performing complaint investigations, root cause investigation and product development focusing on aortic intervention vascular devices. In 2014, Rich joined NAMSA as a Quality Systems Consultant. Over his 16 years in the medical device industry, he has participated in numerous AAMI ISO standards committees and currently sits on the AAMI working groups for AAMI ISO 14971, AAMI ISO/TR24971, AAMI ISO 13485 and AAMI ISO 15223.