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 ...
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 ...
The Globe and Mail

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

Vancouver, British Columbia--(Newsfile Corp. - September 6, 2023) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" or the "Company"), a ...
Finanznachrichten

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

A claim of substantial equivalence does not mean the new and predicate devices needs to be identical. 1 " Given these parameters, Izotropic has selected two predicate devices to support it's Class II ...