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FDA Looks to Give Device Makers More Clearance Options

April 12, 2018, 7:05 PM

Getting a medical device cleared by the FDA might be easier under an agency proposal, but it’s unclear how many devices will wind up being eligible for the new program, regulatory lawyers tell Bloomberg BNA.

The proposal would give device companies—like Baxter International Inc., Stryker Corp., Johnson & Johnson, Fresenius Medical Care AG & Co., and Medtronic PLC—the opportunity to use performance criteria identified by the Food and Drug Administration to show certain medical devices are substantially equivalent to devices already on the market, which are referred to as predicate devices.

Currently, device makers often have to provide data directly...

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