FDA Set to End Notification Requirements for Some Medical Devices
The Food and Drug Administration intends to exempt a lengthy list of Class II and “reserved” Class I medical devices from premarket notification requirements, it said in a draft guidance issued Aug. 1 (here). The agency says the devices “are…
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sufficiently well understood and do not present risks that require premarket notification” under Section 510(k). FDA says it will eventually issue an order in the Federal Register exempting the devices. But in the meantime, FDA says it will not enforce premarket notification requirements for the devices. Comments on the draft guidance are due Sept. 30, said FDA in a concurrent Federal Register notice (here).