New Orthopedic 501(K) Clearance Issued by FDA

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Silver Spring, MD (WorkersCompensation.com) –The Food and Drug Administration (FDA) requires that medical device manufacturers issue notification 90 days prior to intended marketing. The purpose is so that the FDA can classify the device and determine if it is similar to devices previously approved, or is new. The process is known as 501(K).  While the FDA’s process takes into consideration benefit and cost, it is not without its critics, who cite lack of clinical trials and ...

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