Monday, July 27, 2009

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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