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FDA Approves First Generic Device

Generic Medical Devices (Gig Harbor, WA) has received FDA clearance for what it claims is the nation's first generic medical device, a circumcision clamp. The firm says it is the first to market surgical products at generic prices, and this is its first approved product in the United States. If this is indeed an economic model equivalent to generics for drugs, the approval could be a significant milestone in industry history.

But because of the 510(k) approval standard of "substantial equivalence," the industry has a long history of "me too" products. Is GMD's model significantly different from that? The staff of MD&DI will find out when we meet with the company at the MD&M West show next month. Stay tuned.

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