FDA General Controls

General Controls:

Minimum requirements for all device classes. Includes
• Registration of all domestic device manufacturers and importers.
• Listing of all marketed devices by domestic and foreign manufacturers.
• Adhering to Good Manufacturing Practices (GMP’s).
• Filing of Premarket Notification (510k): To notify FDA of the intent to market a medical device.
• Proper device labeling.
• Maintenance of all device records and reports.

General Controls include the provisions of the Act pertaining to:
Adulteration;
Misbranding;
Device registration and listing;
Premarket notification;
Banned devices;
Notification and repair, replacement, and refund;
Records and reports;
Restricted devices; and
Good Manufacturing Practices.