Aug 18, 2011

A final FDA rule affecting ventricular bypass devices, pacemaker repair or replacement material and female condoms goes into effect August 23, 2011. The rule requires manufacturers to file premarket approval applications (PMA) or product development protocols within 90 days of the final rule or cease commercial distribution of their products.

These Class III devices had previously gone through the FDA’s 510(k) premarket notification process as pre-amendment devices that were in distribution prior to the addition of the Medical Device Amendments of 1976 to the Federal Food, Drug and Cosmetic Act.

Specific product codes affected by the final rule are OBY, OKR and KFJ. However, the final rule’s impact is expected to be minimal: all three products have fallen into disuse, and no premarket submissions for any of these device types have been made in several years. (The pacemaker repair and replacement device was last marketed in 2001, and the female condom was last marketed in the 1930s.)

Unsurprisingly, the FDA received no comments from industry on the proposed rule, and expects interest in marketing such devices to stay low (or nonexistent).


  • Stewart Eisenhart