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References to Section 201(h) of the FD&C Act Following the Safeguarding Therapeutics Act

This guidance clarifies how FDA interprets references to section 201(h) of the FD&C Act following the Safeguarding Therapeutics Act, which added a new definition for counterfeit device and redesignated the existing device definition. The guidance aims to provide clarity on how to reference these terms in regulatory documents, communications, and other public documents.

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By ReguVirta
1 min read
  1. Review existing documentation to understand that references to section 201(h) refer to the device definition now in section 201(h)(1)
  2. Update future documentation to:
    • Use section 201(h) or 201(h)(1) when referring to devices
    • Use specific reference to section 201(h)(2) when referring to counterfeit devices
    • Maintain consistency in referencing within the same document
  3. Ensure that any enforcement discretion policies are not applied to counterfeit devices
  4. Align submissions and communications to FDA with these referencing conventions when practicable
  5. Be aware that counterfeit devices are subject to refusal of admission into the United States and may be destroyed by FDA

Key Considerations

Software

  • Software functions excluded pursuant to section 520(o) are not considered devices
  • Existing enforcement policies for device software functions do not apply to counterfeit devices

Other considerations

  • References to section 201(h) in existing documents should be understood to refer to the device definition now in section 201(h)(1)
  • Future references can use either section 201(h) or 201(h)(1) when referring to devices
  • Specific reference to section 201(h)(2) should be used when referring to counterfeit devices
  • Enforcement policies that describe FDA’s intent not to enforce certain requirements do not apply to counterfeit devices

    Relevant Guidances

  • Policy for Device Software Functions and Mobile Medical Applications
  • No specific norms or ISO standards are referenced in this guidance

Original guidance

  • References to Section 201(h) of the FD&C Act Following the Safeguarding Therapeutics Act
  • HTML / PDF
  • Issue date: 2022-11-14
  • Last changed date: 2022-11-10
  • Status: FINAL
  • Official FDA topics: Medical Devices, Biologics
  • ReguVirta summary file ID: 3e6a783da710880c0776e521d2dc8f5d
FDA guidance, Final
Medical Devices Biologics
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