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.
What You Need to Know? 👇
What is the FDA’s jurisdiction for devices that process human cells and tissues at the point of care?
Devices that process HCT/Ps to create therapeutic products are assigned to CBER, while devices for in vitro diagnostic use only are assigned to CDRH. The intended use determines jurisdictional assignment.
Which FDA center regulates cell sorters used for autologous stem cell processing?
Cell sorters used at point of care to isolate/concentrate autologous stem cells for therapeutic re-administration are assigned to CBER for review under device provisions of the Federal Food, Drug, and Cosmetic Act.
How can I get an informal determination about my HCT/P processing device’s regulatory pathway?
Contact CBER at CBERProductJurisdiction@fda.hhs.gov, CDRH at CDRHProductJurisdiction@fda.hhs.gov, or the Office of Combination Products at combination@fda.gov for informal jurisdictional determinations before formal submission.
What is the difference between CBER and CDRH oversight for cell processing devices?
CBER oversees devices creating therapeutic HCT/P outputs for patient re-administration, while CDRH regulates devices producing cells limited to in vitro diagnostic use only, based on intended therapeutic effect.
When should I submit a Request for Designation (RFD) for my cell processing device?
Submit an RFD for formal jurisdictional determination when informal consultation isn’t sufficient. Contact OCP at 301-796-8930 to discuss your situation before submitting, following 21 CFR Part 3 requirements.
What determines if a tissue processing device falls under CBER or CDRH jurisdiction?
The key factor is whether the device’s intended therapeutic effect is mediated by the biologic output. Therapeutic applications go to CBER; in vitro diagnostic-only applications go to CDRH.
What You Need to Do 👇
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