GeneralLast reviewed May 2026

Center for Devices and Radiological Health(CDRH)

The FDA center responsible for ensuring the safety and effectiveness of medical devices and radiation-emitting products.

Usage Examples

CDRH's cardiovascular devices division accepted the 510(k) after RTA review.
The Q-Submission was routed to the OHT orthopedic devices review team.
CDRH issued a postmarket 522 order requiring a five-year surveillance study.

What is CDRH?

The Center for Devices and Radiological Health (CDRH) is FDA's center for medical devices, in vitro diagnostics, and radiation-emitting electronic products. CDRH reviews 510(k) premarket notifications, De Novo classification requests, PMA applications, and IDE supplements, and it oversees the entire device lifecycle from premarket through postmarket surveillance.

CDRH organizes its premarket review across the Office of Health Technology (OHT) divisions, each focused on a device category (cardiovascular, orthopedic, imaging, neurological, etc.). The Office of In Vitro Diagnostics handles IVD submissions. The Office of Product Evaluation and Quality manages 510(k) acceptance and substantive reviews. The Office of Strategic Partnerships and Technology Innovation engages with emerging technologies like AI/ML-enabled devices.

CDRH also maintains key postmarket programs: the Medical Device Reporting (MDR) system for adverse event reports, the MAUDE database for public device event data, the Total Product Life Cycle (TPLC) database, and 522 postmarket surveillance studies. The MDUFA user fee agreement funds CDRH review activities.

Regulatory Context

This term appears most often in general workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside FDCA, MDUFA, 21 CFR PARTS 800 899.

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When This Matters

CDRH's cardiovascular devices division accepted the 510(k) after RTA review.
The Q-Submission was routed to the OHT orthopedic devices review team.
CDRH issued a postmarket 522 order requiring a five-year surveillance study.

Common Mistakes

Relying on generic terminology without mapping to the active jurisdiction context.
Skipping cross-links between terms, tools, and active regulatory references.
Failing to maintain a single source of truth for regulatory definitions internally.

Related Regulations

FDCAMDUFA21 CFR PARTS 800 899

Frequently Asked Questions

Yes. Software that meets the definition of a medical device (Software as a Medical Device, or SaMD) is regulated by CDRH. This includes standalone diagnostic software, software-only clinical decision support, and the software components of physical medical devices.

Through the Q-Submission program. Sponsors file Pre-Submissions to get feedback on predicate selection, testing strategy, clinical study design, and labeling before formal 510(k), De Novo, or PMA filing. Q-Subs are the primary premarket communication channel.

CDRH is the lead center for combination products where the device is the primary mode of action. The Office of Combination Products within FDA determines lead center assignment. For device-drug combinations with a device PMoA, CDRH manages the overall review.