QS & the FDA
- FDA Regulation - Medical device manufacturers must be compliant with several regulations in addition to the FDA Quality System regulation.
- FDA Guidance Documents - Medical device manufacturers must be compliant with several regulations in addition to the FDA Quality System regulation.
- Division of Small Manufacturers, International and Consumer Assistance - The Division of Small Manufacturers, International and Consumer Assistance (DSMICA) provides technical and regulatory assistance to small manufacturers to help them comply with Food and Drug Administration (FDA) requirements for medical devices.
- Device Advice - Device Advice is CDRH`s self-service site for medical device and radiation emitting product information. It is an interactive system for obtaining regulatory information concerning medical devices.