FierceBiotech

FDA’s 510(k) overhaul floats end to predicate testing for some devices

The FDA is planning to expand its abbreviated 510(k) program to lessen the burden of demonstrating substantial equivalence. In draft guidance (PDF), the FDA set out how sponsors can win clearance for ...
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

The FDA should improve device safety by increasing the amount and availability of information about previously marketed devices, known as predicates. Most medical devices reach the market by ...
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 ...
JD Supra

Medical Device Update: FDA Publishes Three New Guidance Documents for the 510(k) Premarket Notification Program

The latest efforts by the U.S. Food and Drug Administration (FDA) to modernize regulation of the 510(k) program come in the form of a trio of new draft guidance documents regarding its Premarket ...