TCTMD

Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

There is a troubling loophole in the US Food and Drug Administration’s 510(k) pathway that allows for the approval of medical devices that are at a higher risk of recall, according to results of two ...
JD Supra

Modernizing the FDA’s 510(k) Program for Medical Devices: Selection of Predicate Devices and Use of Clinical Data in 510(k) Submissions

On September 6, 2023, the US Food and Drug Administration (FDA) released a trio of draft guidances in its efforts to “strengthen and modernize” the 510(k) Program and provide for more “predictability, ...
Health Affairs

Increasing Reliability And Availability Of Information About Devices Used To Support 510(k) Clearance

Most medical devices reach the market by demonstrating they are “substantially equivalent” to previously marketed devices, called “predicates”—a pathway known as “510(k).” Substantial equivalence, ...
FierceBiotech

FDA final guidance modifies 510(k) rules, discourages use of multiple predicate devices

In a new final guidance issued today, the FDA announced that it will frown upon the use of multiple predicate devices in 510(k) submissions, unlike when it cleared metal-on-metal hip implants, which ...