Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing patient Safety and Innovation - Workshop Report
The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
MDA Medical Device Amendments of 1976
MDR medical device reporting
NDA new drug application
NSE not substantially equivalent
PMA premarket approval
QSR quality systems regulation
TPLC total product life cycle