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Classification of Products as Drugs or Devices: Interpretation and Determination Process

This guidance provides clarity on how FDA classifies products as drugs or devices, focusing on the interpretation of statutory definitions and the process for obtaining formal classification determinations. It aims to help sponsors understand the key considerations in product classification and how to obtain classification determinations through the Request for Designation (RFD) process.

  1. Contact the Office of Combination Products (OCP) if uncertain about product classification
  2. When seeking device classification, prepare documentation demonstrating:
    • How the product meets the device definition
    • That primary intended purposes are not achieved through chemical action
    • That the product is not dependent on metabolism for its primary intended purposes
  3. Submit a Request for Designation (RFD) if formal classification determination is needed:
    • Provide complete information as required by 21 CFR 3.7
    • Include justification for recommended classification
    • Present all available relevant data regardless of whether it supports preferred outcome
  4. Consider submitting a pre-RFD for preliminary feedback before formal RFD submission
  5. Monitor for any changes in product characteristics or intended use that may affect classification and submit new RFD if needed
  6. Maintain documentation of classification determination and any subsequent changes

Key Considerations

Other considerations

  • 21 CFR Part 3: Product Jurisdiction
  • 21 USC 321(g): Definition of Drug
  • 21 USC 321(h): Definition of Device
  • 21 USC 360bbb-2: Classification Procedures

Original guidance

  • Classification of Products as Drugs or Devices: Interpretation and Determination Process
  • HTML / PDF
  • Issue date: 2017-09-25
  • Last changed date: 2021-05-13
  • Status: FINAL
  • Official FDA topics: Medical Devices, Combination Products, Drugs, Biologics
  • ReguVirta summary file ID: 4c71952c198b8ce6181b62213dc6831f
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