FDA’s Premarket Approval (PMA) Medical Devices

According to an article written by Cal Warriner, most Americans are unaware that anywhere from 75 to 90 percent of medical devices pass through the 510(k) gate to approval in the U.S. and these are the same devices that are failing in England, Australia and worldwide, as those countries often follow the U.S. lead to approval.

Warriner notes only three metal-on-metal resurfacing hip implants went through the FDA’s premarket approval (PMA) process and were required to provide clinical data to prove safety before they were approved in the U.S. The Birmingham Hip Resurfacing was finally approved in the U.S. in 2006 after initially being denied. It joins the Conserve Plus by Wright Medical, approved by the FDA after a PMA in 2009, and the Cormet by Corin in 2007 – all resurfacing devices.

Unfortunately for the patients who discover after the fact that they are experiencing complications with these PMA devices, they cannot hold the manufacturer accountable due to a U.S. Supreme Court Decision, Riegel v. Medtronics, which gave medical device manufacturers immunity in court if their product received FDA approval.