Biomaterials: Is there a better way for FDA to regulate them?

The medical device industry is pretty conservative when it comes to materials used in medical devices. That begs the question: Do we need a new FDA approval pathway for biomaterials?

Mike Drues thinks the answer is “yes.”

“It really will encourage companies to use new materials and not be hamstrung with materials that have been … used for decades or in some cases even a century,” said Drues, a regulatory consultant based outside Boston who has worked with both medical device companies and FDA.

Drues, who is president of Vascular Sciences, also says the new approval pathway needs to be specific enough to prevent potentially costly and even life-threatening mistakes.

In MDO’s latest podcast, Drues discusses how the medical device industry might go about proposing a new FDA approval pathway that prequalifies innovative materials.

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