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US FDA Lists Hundreds Of Devices For 510(k) Exemption

 
• By Elizabeth Orr

A list of devices being considered for 510(k) exemption includes allergens used in immune system testing, drug tests for employers and denture supplies. The agency is collecting comments through May 15.

Manufacturers won’t need to submit 510(k)s on devices ranging from surgical lamps to tests used to screen employees for drug use if a March 13 proposal from US FDA goes into effect.

The Federal Register notice lists several hundred device "Code of Federal Regulation" categories and a total of 1,003 class II device-types, including specific allergen tests within a...

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