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 isÂ 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.
ButÂ because ofÂ 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 staffÂ of MD&DI will find out when we meet with the company at the MD&M West show next month. Stay tuned.