Continuous Quality: FDA’s Goal for the Case for Quality Program

USA – Continuous Quality: FDA’s Goal for the Case for Quality Program

About five years ago, when FDA started looking at the number of recalls and warning letters to medical device manufacturers, the agency realized that...
FDA issues revised draft guidances for blood glucose monitors

USA – FDA issues revised draft guidances for blood glucose monitors

The FDA issued two revised draft guidances today relating to over-the-counter and prescription blood glucose monitors. The new documents, which are intended to update guidances issued...
FDA : New steps to strengthen the process of initiating voluntary recalls

USA – FDA : New steps to strengthen the process of initiating voluntary recalls

Voluntary recalls are one of the most important safety tools overseen by the U.S. Food and Drug Administration. They are a vital means to...
Ghosts of Medtech: What Ever Happened to These 7 Medical Devices?

USA – Ghosts of Medtech: What Ever Happened to These 7 Medical Devices?

Sometimes even seemingly good ideas just don't pan out. Read on to see seven medtech products that once held a lot of promise but just...
FDA Revises 1989 Guidance on Drug Master Files

USA – FDA previews safety-focused STeP pathway, finalizes breakthrough device guidance

The FDA today outlined its plans for finalizing guidance on its Breakthrough Device Program as well as plans for a new Safer Technologies Program...
Coronavirus delays many FDA foreign inspections

USA – FDA proposes to end quarterly reporting of medical device decisions

The US Food and Drug Administration (FDA) on Monday proposed revisions to its medical device regulations to end its practice of publishing quarterly lists...
Applied Tissue Technologies’ negative-pressure dressing gets FDA nod

USA – Researchers Call on FDA to Tighten Requirements for Breakthrough Devices

A team of researchers are calling on the US Food and Drug Administration (FDA) to require more evidence and impose stricter limits on medical...
Benefits of ERP in an FDA-Regulated Environment

USA – Benefits of ERP in an FDA-Regulated Environment

This guide will examine how medical device manufacturers are increasingly turning to ERP systems to mitigate compliance risk and turn developmental concepts into commercialize...
FDA Urges Caution in Use of Robotic Surgical Devices for Cancer-Related Procedures

USA – FDA Urges Caution in Use of Robotic Surgical Devices for Cancer-Related Procedures

Patients and health care providers should know that the safety and effectiveness of robotically-assisted surgical devices for the prevention or treatment of cancer has...
Contact Lenses: CDRH Drafts Guidance on Performance Criteria to Support 510(k)s

USA – FDA issues guidance on PMA, HDE supplements amid COVID-19

The US Food and Drug Administration (FDA) on Thursday issued an immediately effective guidance allowing medical device makers to make “limited modifications” to their...

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