On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its anticipated compliance program manual, ...
Key Takeaways - FDA’s 2026 guidance clarifies when digital health tools fall outside device regulation. Updated policies for clinical decision ...
Industry consultant Michael Drues will discuss how medical device companies can better prepare for FDA inspections.
Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will ...
FDA warning letter data reveals the same top 10 compliance issues have plagued medtech for 20 years, with CAPAs leading at 12 ...
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 ...
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 ...
In a regulatory milestone, the FDA clears AuraWell’s PEMF technology as the first over-the-counter frequency therapy device for at-home recovery.
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 ...
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 ...
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