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Jurisdictional Determinations for HCT/P Processing Devices: CBER vs CDRH Assignment

This guidance clarifies the jurisdictional determinations for devices used to process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), specifically focusing on whether these devices should be regulated by CBER or CDRH based on their intended use.

  1. Determine the intended use of the device (therapeutic vs. diagnostic) early in development
  2. Identify the appropriate reviewing center (CBER or CDRH) based on intended use
  3. Contact the Office of Combination Products (OCP) for preliminary discussion before submitting any formal requests
  4. Consider submitting a Request for Designation (RFD) if formal determination is needed
  5. Ensure device labeling clearly indicates intended use and limitations
  6. Consult with CBER for specific regulatory pathway information if device is intended for therapeutic use
  7. Document all jurisdictional determinations and communications with FDA
  8. Review applicable guidance documents specific to the product type from the assigned center

Key Considerations

Labelling

  • Products intended for in vitro diagnostic use must be clearly labeled as such
  • Labeling must specify limitations regarding readministration of processed materials

Other considerations

  • 21 CFR Part 3: Administrative Practices and Procedures for FDA regulations

Original guidance

  • Jurisdictional Determinations for HCT/P Processing Devices: CBER vs CDRH Assignment
  • HTML / PDF
  • Issue date: 2007-07-01
  • Last changed date: 2021-05-13
  • Status: FINAL
  • Official FDA topics: Medical Devices, Combination Products, Drugs, Biologics
  • ReguVirta summary file ID: d05689ee01f6dc2ae99bd9a52dd0eeff
This post is licensed under CC BY 4.0 by the author.