Discover what regulated markets are, how they work, and their advantages and disadvantages. Learn how government oversight ...
The FDA ImportShield Program centralizes import review, increasing processing speed by 66% and volume capacity by 33%, while ...
On Jan. 6, 2026, the U.S. Food and Drug Administration (FDA) updated the final guidance documents General Wellness: Policy for Low Risk Devices (the General Wellness Guidance) and Clinical Decision ...
In four months, the program, which aims to modernize how the FDA reviews imported products, increased processing speed by 66% ...
Industry consultant Michael Drues will discuss how medical device companies can better prepare for FDA inspections.
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