FDA Asked for ‘Overhauled, Streamlined’ 510(k) Database

In a letter, the two pointed to reports over the past several years of patients being seriously harmed or even killed by medical devices such as artificial hips and mesh implants indicated for urinary incontinence in women.

“A flaw in the 510(k) process opens the door for defective devices to make their way onto the market and jeopardize patient safety,” Markey and Merkley asserted. “Current law requires FDA to clear a device shown to be substantially equivalent to a predicate, even in cases where the new product contains the same flaws as an earlier model that had to be recalled by the manufacturer due to a fundamental design flaw.”

The lawmakers said they believe the solution requires an expansion of FDA’s authority to enable it to reject clearance if a device repeats design flaws that have led to the voluntary recall of earlier products. That change is embodied in H.R. 3847, the “Safety of Untested and New Devices Act,” they wrote.

Te two believe that providing device manufacturers, the public, and medical professionals with better information about devices recalled for serious design flaws could help avoid future injuries.

Markey and Merkley asked that FDA update its 510(k) database to reflect:

“In these cases,” they wrote, “the database entry for such a device should provide a link to information about the predicate’s adverse event reports and recall, so that consumers and doctors can determine the nature of the earlier problem.”

The letter included a number of questions for Shuren to answer about whether CDRH will take specific steps the lawmakers are requesting and reasons for not agreeing to them if that is the case.