Medical Device Labeling Compliance & UDI – XPRO AMERICA

Accurate and compliant device labeling is critical to ensure safety, regulatory adherence, and market access in the United States. Under 21 CFR Part 801, the FDA requires medical devices to…
Accurate and compliant device labeling is critical to ensure safety, regulatory adherence, and market access in the United States. Under 21 CFR Part 801, the FDA requires medical devices to…
The De Novo classification pathway is designed for novel, low- to moderate-risk medical devices that do not have a predicate device for 510(k) submission. This pathway allows manufacturers to obtain…