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CDRH vs CBER — Which Center Applies?

FDA is organised into several centres, each with responsibility for specific product categories. Most medical devices are regulated by CDRH, but a subset of device-related products fall under CBER.

US-unique

The CDRH/CBER split is a US-specific structure with no direct parallel in the TGA, CE, Health Canada, or HSA frameworks. Understanding which centre applies is essential before preparing any FDA submission.

Center for Devices and Radiological Health (CDRH)​

CDRH is the primary FDA centre for medical devices. It regulates:

  • The vast majority of medical devices — Class I, II, and III
  • In vitro diagnostic (IVD) devices (most)
  • Radiation-emitting electronic products (X-ray, laser, ultrasound)
  • Combination products where the device component provides the primary mode of action

CDRH key programmes:

  • 510(k) clearance
  • Premarket Approval (PMA)
  • De Novo classification
  • Humanitarian Device Exemption (HDE)
  • Breakthrough Device Designation
  • Digital Health Center of Excellence (DHCoE)

Center for Biologics Evaluation and Research (CBER)​

CBER regulates biological products, including certain device-related products where the biologic component is primary. CBER has jurisdiction over:

Product typeExamples
Blood and blood componentsBlood collection devices, apheresis equipment
Cellular and gene therapiesCAR-T delivery devices, gene therapy vectors
Tissue and tissue-based productsBone grafts, skin substitutes (when biologic)
Vaccines and related biologicsVaccine delivery devices may go to CBER
Allergenic productsSkin test devices for allergens

Combination products and PMOA​

When a product combines device and biologic components, the primary mode of action (PMOA) determines the lead centre:

  • PMOA is device → CDRH leads
  • PMOA is biologic → CBER leads

For products where PMOA is uncertain, submit a Request for Designation (RFD) to FDA's Office of Combination Products (OCP) under 21 CFR Part 3. OCP issues a binding designation within 60 days.

Practical guidance​

  1. Search FDA's Product Classification Database — the product code entry will show which office regulates it.
  2. Review the 510(k) database — accepted submissions appear under the regulating centre.
  3. If uncertain, contact FDA's OCP or submit an RFD.
  4. For novel products with no clear precedent, a Q-submission (Pre-Sub) to CDRH is a good first step.

Official resources​