We’ve got a good one for you today. In episode #8 of the Global Medical Device Podcast we welcome back Michael Drues, president of Vascular Sciences. As many of our listen may recall, Mike does consulting for medical device companies, the FDA, Health Canada and other regulatory bodies.

Today Jon and Mike talk about 510(k)s and some of the major mistakes some companies make when they get 510(k) clearance. Specifically, they talk about companies that get 510(k) clearance but don’t have design controls, risk management and don’t have a quality system.

And it’s chuck full of actionable advice and takeaways.

“70-75% of 510(k) and PMA submissions are rejected the first time.” -Mike Drues

The FDA’s mission is to make sure the products we bring to market are safe and effective. The 2 areas of 510(k) submissions that are getting the most scrutiny are the substantial equivalents argument and the risk mitigation strategy.

If you don’t have a rock solid argument and a bulletproof strategy you will probably be rejected. Early and frequent communication with the FDA is the key to success.

“Design controls are nothing more than a synonym for prudent engineering.” - Mike Drues

Today Mike and Jon talk about:

When a 510(k) isn’t necessary

Reasons for rejection of a 510(k)

“Lead don’t follow, tell don’t ask.”

Design controls

Multiple Predicate Strategy / Split Predicate Strategy

Risk Mitigation

Regulatory checks

Corrective Action/Preventative Action Plan

“Physicians can kill patients one at a time but an FDA reviewer can kill patients thousands at a time.” -Mike Drues

What can a company do if they’ve been approved for market but aren’t prepared? Conduct a gap analysis, figure out what you have, figure out what’s missing, fill in what’s missing and be upfront about it.

Ask for help if you need it. Go to the experts. There is so much more we can do to help before, rather than cleaning up problems later, but, “It’s never too late to do the right thing.” -Jon Speer