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.
Recommended Actions
- Determine the intended use of the device (therapeutic vs. diagnostic) early in development
- Identify the appropriate reviewing center (CBER or CDRH) based on intended use
- Contact the Office of Combination Products (OCP) for preliminary discussion before submitting any formal requests
- Consider submitting a Request for Designation (RFD) if formal determination is needed
- Ensure device labeling clearly indicates intended use and limitations
- Consult with CBER for specific regulatory pathway information if device is intended for therapeutic use
- Document all jurisdictional determinations and communications with FDA
- 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
- Devices that process HCT/Ps ex vivo to create therapeutic articles where the therapeutic effect is mediated by the biologic output are assigned to CBER
- Cell sorters for isolating/concentrating autologous stem cells or hematopoietic progenitor cells for in vivo use are assigned to CBER
- Devices processing autologous blood/tissue to produce new HCT/Ps at point of care for direct readministration are assigned to CBER
- Cell sorters for isolating/concentrating cells for in vitro diagnostic use only are assigned to CDRH
Relevant Guidances
- How to Submit a Request for Designation (RFD) for Product Classification and FDA Center Assignment
- How to Submit a Pre-Request for Designation (Pre-RFD) for Product Classification and Center Assignment
- Classification of Products as Drugs or Devices: Interpretation and Determination Process
Related references and norms
- 21 CFR Part 3: Administrative Practices and Procedures for FDA regulations
Original guidance
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