Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents

October 2, 2019

change to version of title

If you haven’t realized it yet, risk management in the medical device industry isn’t going away. How do you navigate, capture, and document when and what to do?

In this episode, Jon Speer invites guest Mike Drues of Vascular Sciences to join the show as the two discuss FDA’s two, new guidance documents that provide additional transparency, consistency, and objectivity regarding benefit-risk determinations.



Like this episode? Subscribe today on iTunes or Spotify.


Some of the highlights of the show include:

  • Differences between Documents: Under what circumstances that pose a greater risk are acceptable for product submissions vs. appendices related to ISO 14971.
  • New nine-page benefit-risk assessment worksheet is oversimplified and presents a non-traditional instead of analytical approach to determining benefit-risk.
  • New guidance documents don’t mention 510(k) device, but why? People should already know about uncertainty and risk of 510(k) medical devices via predicates.
  • Higher risk is acceptable in various classifications of medical devices, including PMAs and BDPs, and when dealing with small populations.
  • Adding to the complexity of medical devices, the guidance documents now include low-, medium-, and high-risk categories and criteria of uncertainty.
  • Pay attention to patient’s perspective of uncertainty when available. Are patients willing to truly accept risks and uncertainty to achieve unmet clinical need?
  • Mitigate uncertainty in other ways, such as through labeling, degree of need, and clinical evidence/market data of product.
  • Probable Benefit of HDE: Efficacy at a lower statistical power may diminish uncertainty due to giving patients early access to a medical device.



Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions

Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications

FDA Breakthrough Devices Program (BDP)

Understanding ISO 14971 Medical Device Risk Management

510(k) Premarket Notification

Premarket Approval (PMA)

Classify Your Medical Device

Webinar: Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions – Final Guidance

Greenlight Guru Webinars

Using the Bucket Method for Medical Device Risk Management

Mike Drues

MedTech True Quality Stories Podcast

Greenlight Guru True Quality Roadshow

Greenlight Guru


Memorable Quotes by Mike Drues:

“Risk or uncertainty...has always been included in all product reviews of medical devices.”

“We’re creating yet another scale, another metric when we talk about uncertainty or risk. Risk is a complicated topic. It seems like we’re making it even more complicated.”

“They want to have a flexible and tailored approach in reviewing each device by itself ...and considering the totality of the evidence.”  

“I am not a fan of the cookie-cutter approach to medical device development. Every medical device...should be considered on its own merits.”



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 and companies.

Like this episode? Subscribe today on iTunes or Spotify.

Nick Tippmann is an experienced marketing professional lauded by colleagues, peers, and medical device professionals alike for his strategic contributions to Greenlight Guru from the time of the company’s inception. Previous to Greenlight Guru, he co-founded and led a media and event production company that was later...

Search Results for:
    Load More Results