Beck 2024 510 K

Beck 2024 510 K. Redirecting the regulatory strategy from the special 510(k) to the traditional 510(k) submission pathway. The document, entitled “submission and review of sterility information in premarket notification (510 (k)) submissions for devices labeled as sterile,” provides.

Fda and eu regulations are now more closely aligned thanks to the recent implementation of eu mdr. This guidance provides recommendations for when clinical data may be needed.