When bringing a medical device to the market, it’s important to be aware of the fatal 510(k) flaw. In today’s episode, Mike Drues joins the podcast to discuss the potential issues the 510(k) program presents and how companies are dealing with it.

Mike holds a Ph.D. in biomedical engineering, has served as an expert witness, and is one of the foremost regulatory minds, currently serving as the president of Vascular Sciences. Listen to today’s conversation to learn how to approach a 510(k) submission if your predicate had a recall, how to develop products that are safer and more effective, and the importance of tracing the genealogy of your predicate. 

Some of the highlights of this episode include:

• What happens when the predicate that you’d like to use for your 510(k) has undergone a Class 1 recall
• The risk management element of using a predicate that’s undergone a Class 1 recall
• The statistics about recall predicates used in 510(k)s
• How the way the 510(k) is used has changed since it was first created
• Why the descendants of a predicate with a Class 1 recall are so much more likely to also undergo a recall
• Solving the problem of a predicate that’s been through multiple recalls
• Considering competitor’s products or other products similar to the one yours is based on
• What post-market surveillance should entail
• The direct and indirect economic impact of a Class 1 recall
• Changes that may happen with the FDA in the future

Memorable quotes from Mike Drues:

“I can tell you that of the total number of devices that come onto the market, less than 5% are Class 3s.”

“When the 510(k) was created half a century ago, it was intended to be an exception, not the rule.”

“I do not advocate these simple-minded solutions like no 510(k) should allow to use a predicate that’s undergone a recall.”

“Unfortunately, good news does not sell. Bad news sells.”

Links:

Mike Drues

Vascular Sciences

510(k) Guidance

JAMA Study 1

JAMA Study 2

FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours

Ultimate Guide to Postmarket Surveillance of Medical Devices

Etienne Nichols LinkedIn

Greenlight Guru Academy

Greenlight Guru