How is My Medical Device Classified? скачать в хорошем качестве

FDA

CDRH

Center for Devices and Radiological Health

medical devices

radiation-emitting devices

device classification

product classification

Class I Medical Devices

Class II medical devices

III medical devices

device determination

device listing

device approval

traction device

regulatory controls

general

special or premarket approval controls

Premarket Approval Application (PMA)

Premarket Notification

510(k) clearance

FDA product codes

513(g) Request