The FDA set an August 23 date for a final rule for three “fallen angel” class III devices to submit premarket applications or be taken off the market as their existing 510(k) cleared status has been revoked.
The term “fallen angel” refers to medical devices that were once candidates for the FDA’s fast-track 510(k) review but have since been relegated to the more stringent premarket approval path.
“All companies that previously had a 510(k) cleared would need to come in with a PMA within 90 days post August 23, 2011 if they are interested in continuing to market their device,” FDA spokesperson Erica Jefferson told MassDevice.
Products affected include certain ventricular bypass devices, pacemaker repair and replacement products and a type of female condom.
The rule was initially proposed August 25, 2010, and no comments or requests for reconsideration were received within the 15-day comment period, Jefferson told us.
The watchdog agency doesn’t expect a large impact resulting from the decision, “because there have been no premarket submissions for these devices in the past 5 years and all of the affected devices have fallen into disuse,” according to the final rule notice.
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