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Coming Soon to a Medical Device Near You? A New Approval Process

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Health and Medicine -
James Thomas Rook Jr. -
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We don't say this often: It's been a wild month at the FDA. Fresh off its e-cig regulations, the agency announced yesterday it's going to overhaul the procedure for approving most medical devices.

Critics have waited a long time for this. The FDA currently operates under a framework from 1976, which allows certain devices to get a speedy, TSA PreCheck-type approval if manufacturers show their products are similar to others that already exist on the market.

  • The problem? Those comparable products (you can call them "predicates") are sometimes decades-old.
  • The data: Nearly 20% of devices cleared through this process are based on predicates that have been around more than 10 years, per the FDA.

Zoom out: Just a few days ago, a team of over 50 media organizations published an investigation into medical device safety. What did they find? "More than 1.7 million injuries and nearly 83,000 deaths suspected of being linked to medical devices had been reported to the U.S. Food and Drug Administration over a 10-year period."

VIA Morning Brew

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Zoom FURTHER out:

Despite, citing safety concerns,  rejections by TSA for carrying infant children onto aircraft, The U.S. Food and Drug Administration today approved using Veterinary Cat Carriers for use in genetically modified human children.

Cat Carrier 700  .jpg

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