Episode 343

#343: Recent FDA Draft Guidances


In this episode, we discuss with with regulatory expert Mike Drues to dissect the evolving landscape of FDA medical device regulations. These discussions provide a comprehensive overview of the historical context and current implications of FDA guidances, with a particular focus on 510K predicate selection, clinical data requirements, and the nuances of permanent implants. The conversations address the challenges and complexities inherent in aligning medical device design and development with contemporary FDA expectations and offer invaluable insights for professionals in Product Development, Quality Assurance, and Regulatory Affairs.

Some of the highlights of this episode include:

  1. How the 510K, originally an exception, has ironically become the predominant pathway in medical device regulation.
  2. That, despite efforts to raise regulatory compliance standards, the enforceability of current guidances is limited due to unchanged regulations.
  3. Discussion of FDA's non-binding guidances balance between being commendable for clarity and somewhat overreaching, reflecting a nuanced industry challenge.
  4. How evolving FDA thinking underscores the importance of aligning with contemporary standards, going beyond mere compliance.
  5. That selecting predicates with past design-related recalls for 510K submissions poses legal challenges and necessitates reevaluating older predicates in light of new risks.
  6. How clinical data requirements in medical device regulation are dictated by engineering and biological factors, not just regulatory pathways.
  7. How demonstrating substantial equivalence can be complex, and small technological differences must not introduce new safety concerns.
  8. The definition of 'permanent implant' challenges traditional understanding, emphasizing the importance of biocompatibility and safety in regulation.


"Just because you're meeting the standard, that just means that you're passing... That doesn't necessarily mean that you're making a safe and effective product." – Mike Drues

Reference Links:

*Interested in sponsoring an episode? Click here to learn more!

About the Podcast

Show artwork for Global Medical Device Podcast powered by Greenlight Guru
Global Medical Device Podcast powered by Greenlight Guru
The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts ...

About your host

Profile picture for Etienne Nichols

Etienne Nichols

Mechanical Engineer, Medical Device Guru, and host of the Global Medical Device Podcast