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, ...
JD Supra

FDA fills 510(k) guidance gaps with drafts on predicate devices, clinical data, implantables

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has issued three new draft guidances as part of an effort to modernize its 510(k) Program for new products ...
MobiHealthNews

FDA looks to restrict older predicate devices, introduce new regulatory pathway

Yesterday, the FDA announced in a press release that it is eyeing potential updates to the agency’s 510(k) clearance pathway for medical devices. These could include a requirement for more modern ...
Healio

'Meaningful percentage' of approved orbital implants based on recalled predicate devices

Please provide your email address to receive an email when new articles are posted on . Some currently marketed orbital implants were cleared through equivalence to a later-recalled device, according ...
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 ...
MedCity News

FDA considering imposing 10-year limit when manufacturers choose older predicates

Food and Drug Administration’s modernization plan for its 510(k) process may not be all sweet music to the industry. In a joint statement on Monday describing the modernization effort, Commissioner ...
MobiHealthNews

FDA finalizes new 510(k) guidance, shifts away from aging predicate devices

Looking to modernize the 510(k) process, yesterday the FDA announced its final guidance establishing the framework for the new Safety and Performance Based Pathway. The biggest change to the 510(k) ...
The Globe and Mail

Izotropic Files Class II Pre-Submission with FDA & Releases Details on Predicate Devices

Vancouver, BC – TheNewswire – September 6, 2023 – Izotropic Corporation (“Izotropic” or the “Company”) (CSE:IZO) (OTC:IZOZF) (FSE:1R3), a medical device ...
STAT

FDA proposes changes to key approval pathway for medical devices, five years after promising

Five years after promising to fix a flawed regulatory pathway widely used by medical device manufacturers, the Food and Drug Administration has issued new guidelines to improve its so-called 510(k) ...
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 ...
BioWorld

JAMA article says three recalls for predicate devices drives recalls of follow-on devices

The U.S. FDA’s 510(k) program is yet again under assault, this time from the authors of a Jan. 10 article in the Journal of the American Medical Association (JAMA). The authors’ primary point seems to ...