JD Supra

FDA updates compliance program inspection manual for the QMSR age

On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its anticipated compliance program manual, ...
JD Supra

The QMSR Goes Live and FDA Implements a New Medical Device Inspection Technique

On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice ...
Medical Device and Diagnostic Industry (MD+DI)

How Medical Device Companies Can Avoid Costly FDA Inspection Mistakes

Industry consultant Michael Drues will discuss how medical device companies can better prepare for FDA inspections.
MedTech Dive

FDA guidance eases wearables oversight. But experts have questions about what’s next.

Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will ...
Medical Device and Diagnostic Industry (MD+DI)

Inside the Most Common FDA Inspection Issues

FDA warning letter data reveals the same top 10 compliance issues have plagued medtech for 20 years, with CAPAs leading at 12 ...
HealthLeaders Media

FDA relaxes rules for wearable health devices

The FDA has announced that it will relax portions of its regulatory framework governing wearable health devices, a move the agency says is designed to encourage innovation and expand consumer access ...
Hosted on MSN

FDA scraps ‘Final Rule’ classifying LDTs as medical devices

The US Food and Drug Administration (FDA) has chosen to axe its ‘Final Rule’ from May 2024, bringing to an end a long-running agency-industry dispute around the proposed classification of ...
Becker's Hospital Review

FDA loosens data rules for select medical device submissions

The FDA has eliminated a key barrier to the use of real-world evidence in certain medical device applications. Under new guidance issued Dec. 15, the agency said it will accept real-world evidence ...

Hemex Health Receives FDA Breakthrough Device Designation for Gazelle® Hb Variant Test

The Gazelle Hb Variant Test has not been cleared or approved by the FDA and is not available for sale in the United States. Breakthrough Device Designation does not guarantee regulatory clearance.
Healthline

Which Products Does the FDA Regulate?

The Food and Drug Administration (FDA) regulates medications, medical devices, foods, cosmetics, certain electronic devices, pet and livestock products, and tobacco products. FDA regulation involves ...
ConsumerAffairs

FDA relaxes rules for wearable health devices

The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices. Officials say the move is intended to speed innovation while maintaining ...