Guide Development Medical Device Regulations

Overview of Device Regulation | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

Medical Device Listing - 21CFR Part 807 Manufacturers must list their devices with the FDA. Establishments required to list their devices include: manufacturers, contract manufacturers,...

Recent Final Medical Device Guidance Documents | FDA

https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/recent-final-medical-device-guidance-documents

Jan 12, 2023

Quality System (QS) Regulation/Medical Device Good …

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

Guide to Medical Device Regulation | Thompson FDA

https://fda.thompson.com/Guide-to-Medical-Device-Regulation

The Guide to Medical Device Regulation is an in-depth analysis of the FDA's requirements for medical devices — a practical guide that will aid you in making informed and efficient decisions by giving you information on the most up-to-date regulatory developments.