Three medical devices face removal from the market if their manufacturers fail to file applications for premarket approval with the FDA by Nov. 21. But the Aug. 16 ruling is essentially moot because the affected devices—a ventricular-assist device, various pacemaker repair products and a version of the female condom—are out of date.
“These three device types are no longer being marketed, and have in fact been replaced by newer technology regulated under different classifications, so we expect this rule to have little to no impact on industry,” FDA press officer Erica Jefferson said during an interview.
Still, this latest 515(i) ruling may stand as an object lesson for medical-device manufacturers that may still be marketing devices designed before the Medical Device Act of 1976.
The action also comes at a time when the FDA’s evolving premarket-approval process is much in the news with new draft guidance and its 510(k) “substantial equivalence” precedent is under intense scrutiny by consumer groups.
“Note that the recent effort associated with the 515(i)s is stemming from a 2009 GAO report that called on the CDRH [FDA’s Center for Devices and Radiological Health] to address the remaining 26 pre-amendment devices that have been regulated as Class III 510(k)s, and appropriately classify these devices, either by downclassifying them with appropriate special controls or calling for PMAs,” wrote Jefferson in a follow-up email. “These three products are part of the Class III devices being regulated through the 510(k) program.
“In April 2009, a call for safety and effectiveness information was put out for each of these device types and as part of CDRH's 2011 strategic initiatives, and we publicly indicated that we are going through the process to appropriately classify the remaining devices that fall into this unusual category.”