Center for Devices and Radiological Health(CDRH)
CDRH is the FDA center that regulates medical devices and radiation-emitting electronic products in the United States.
Usage Examples
- The company prepared a pre-submission package for CDRH feedback.
- CDRH reviewed the 510(k) substantial-equivalence rationale.
- Postmarket surveillance updates were filed per CDRH requirements.
What is CDRH?
The Center for Devices and Radiological Health (CDRH) oversees device premarket pathways such as 510(k), De Novo, and PMA, and enforces quality-system and postmarket requirements. CDRH evaluates device safety and effectiveness evidence, manufacturing controls, labeling, and real-world performance throughout the product lifecycle.
Regulatory Context
This term appears most often in medical devices workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 807, 21 CFR 814, 21 CFR 820.
When This Matters
- The company prepared a pre-submission package for CDRH feedback.
- CDRH reviewed the 510(k) substantial-equivalence rationale.
- Postmarket surveillance updates were filed per CDRH requirements.
Common Mistakes
- Using drug-only submission assumptions for device regulatory pathways.
- Ignoring post-market obligations in pre-market planning.
- Weak predicate and classification rationale in dossier narratives.
Related Regulations
Frequently Asked Questions
CDRH regulates medical devices and radiation-emitting products, including premarket submissions and postmarket controls.
CDRH reviews pathways such as 510(k), De Novo, PMA, and related supplements for eligible devices.
Yes. CDRH oversees compliance with device quality-system requirements and postmarket reporting obligations.
Related Terms
Related Use Cases
Prepare 510(k), PMA, and De Novo submissions with AI-guided pathway selection
Manage 15+ client programs from one dashboard with per-client workspaces and tracking
Cut regulatory intelligence tracking from 10+ hours/week to automated, real-time alerts
Track GxP regulation changes and enforcement trends
Related Regulatory Intelligence
Related Actions
Sources & References
