31

2024.01

Quality System (QS) Regulation/Medical Device Current Good Manufacturing Practices (CGMP)

source from：https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp

Detail

06

2023.09

CDRH Statement: FDA Continues to Take Steps to Strengthen the Premarket Notification [510(k)] Program

source from：https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-statement-fda-continues-take-steps-strengthen-premarket-notification-510k-program 

Detail

17

2023.07

Clinical Laboratory Improvement Amendments (CLIA)

source from：https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clinical-laboratory-improvement-amendments-clia?utm_medium=email&utm_source=govdelivery 

Detail

24

2023.07

CDRH Announces New Standards Recognition to Support Innovation in Medical Device Sterilization

source from: https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-new-standards-recognition-support-innovation-medical-device-sterilization 

Detail

02

2023.03

Total Product Life Cycle Advisory Program (TAP)

source from: https://www.fda.gov/medical-devices/how-study-and-market-your-device/total-product-life-cycle-advisory-program-tap?utm_medium=email&utm_source=govdelivery 

Detail