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

[Image from Unsplash]

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.

Listen to the full podcast with Drues on our sister site Medical Design & Outsourcing.

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