General Control

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General controls are regulatory requirements authorized by the Food, Drug and Cosmetic Act, under sections 501, 502, 510, 516, 518, 519, and 520. General controls apply to all medical devices and drugs, unless exempted by regulations. If a device or drug is exempted from one of the general controls, such exemption is stated in the classification regulation for that device. The devices subject to only general controls are Class I devices (the lowest risk class).  

General controls are described in the following sections of the FD&C Act:

  • 501: Adulterated drugs and devices,  
  • 502: Misbranded drugs and devices
  • 510: Registration of producers of drugs or devices (Establishment registration and device listing, Premarket Notification (510k), Reprocessed single-use devices)
  • 516: Banned devices
  • 518: Notifications and other remedies (Notification, Repair, Replacement, Refund, Reimbursement, Mandatory recall)
  • 519: Records and reports on devices (Adverse event report, Device tracking, Unique device identification system, Reports of removals and corrections)
  • 520: General provisions respecting control of devices intended for human use (Custom device, Restricted device, Good manufacturing practice requirements, Exemptions for devices for investigational use, Transitional provisions for devices considered as new drugs, Humanitarian device exemption)

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About the Author
Proxima CRO Team
Joel Reid
Regulatory Affairs Associate

Joel has a Bachelors Degree in Psychology and German. He also has undergraduate research experience in neuroimaging at the Waco VA.

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