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    General Controls

    Baseline FDA requirements that apply to all medical devices regardless of class.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    General Controls include establishment registration, device listing, premarket notification (where required), prohibition of adulteration/misbranding, labeling, GMP/QS requirements, and recordkeeping. They form the floor under every device class.

    What this means in practice

    Class I devices are typically regulated by General Controls alone; Class II adds Special Controls, and Class III requires PMA on top of both.

    Primary references

    3 sources
    Link health: 2 verified 1 bot-blocked· last checked 2026-05-09
    FDA·2RAPS·1
    1. 1
      FDA General Controls
      Bot-blocked
      FDAfda.gov
    2. 2
      RAPS Regulatory Focus
      Verified
      RAPSraps.org
    3. 3
      FDA - Medical Devices
      Verified
      FDAfda.gov

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