CDRH

The Center for Devices and Radiological Health (CDRH) is one of six product centers within the U.S. Food and Drug Administration (FDA). CDRH is responsible for protecting and promoting public health by ensuring the safety and effectiveness of medical devices and radiation-emitting products.

CDRH responsibilities include:
- Premarket review of medical devices (510(k), PMA, De Novo)
- Establishment registration and device listing
- Post-market surveillance and vigilance
- Compliance and enforcement activities
- Development of guidance documents and regulations
- Oversight of radiation-emitting products

Key CDRH offices:
- Office of Product Evaluation and Quality (OPEQ) - Reviews device submissions
- Office of Surveillance and Biometrics - Post-market monitoring
- Office of Compliance - Enforcement and inspections
- Office of Science and Engineering Laboratories - Scientific review

Device classification:
CDRH classifies medical devices into three classes based on risk:
- Class I - Low risk, general controls (most exempt from 510(k))
- Class II - Moderate risk, special controls (510(k) required)
- Class III - High risk, premarket approval (PMA required)

Interacting with CDRH:
- Pre-submission (Pre-Sub) meetings available
- Breakthrough Device Designation for innovative products
- CDRH Learn for training and education
- Electronic submission through eSTAR

CDRH regulates over 190,000 different devices from simple bandages to complex implants.