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 ...

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 Food and Drug Administration (FDA) is preparing to implement changes to its medical device clearance process that would rely far less on older predicate devices and offer a modernized pathway for ...

The FDA plans to revamp how it clears medical devices through an expedited approval process called the 510(k) pathway, FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, director of the Center ...

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

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 ...

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 In draft guidance (PDF), the FDA set out how sponsors can win clearance for ...

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 ...

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) ...