FDA Medical Device Controversies - Approvals and Clearance

I thoroughly enjoyed reading this Health News Digest article, Is That Medical Device Safe And Effective? Who Knows?

It's a great overview of:

• medical device classification
• premarket approval (PMA)
• premarket notification (510(k))
• substantially equivalent
• anecdotes that highlight controversies in the items above. This is the best part of the article.

For me, I get the sense that it's generally about business, and that some unethical companies might be putting our collective safety at risk.

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