The 510(K) Third Party Review Program: Promise and Potential

20.500.12592/jv81j0

The 510(K) Third Party Review Program: Promise and Potential

16 Mar 2023

Since the passage of the Medical Device Amendments of 1976, the FDA’s the Center for Devices and Radiologic Health (CDRH) has been responsible for regulating medical devices. These devices have a broad array of complexity and risk profiles, ranging from elastic bandages to robotic surgical equipment. Moreover, the medical device industry is rapidly innovative: between
fda medical technology health care policy

Authors

Brian J. Miller, William Blanks, Brian Yagi

Published in
United States of America