FDA Center For Devices and Radiological Health
CDRH protects the public health by providing reasonable assurance of the safety and effectiveness of medical devices and by eliminating unnecessary human exposure to radiation emitted from electronic products.
- FDA's Role in Fostering the Development of Better Medical Devices
Jeff Shuren, Director of FDA’s Center for Devices and Radiological Health, discusses FDA's role in the development of better medical devices.
- FDA Centennial at CDRH
Commemorates the 100th anniversary of Food and Drug Administration (FDA) and the major milestones celebrated by the Center for Devices and Radiological Health (CDRH) in 2006.
- CDRH Organizational Chart
Provides names and phone numbers of those working in key positions at CDRH.
- Referral List
Provides information on who to contact for assistance with particular issues.
- Medical Devices - Industry Assistance
Provides assistance for small manufacturers and other domestic and foreign producers of medical devices and radiation-emitting electronic products.
- Radiation-Emitting Products - Industry Assistance
Provides information for manufacturers of radiation emitting products.
- FDA's New Office of In Vitro Diagnostic Device Evaluation and Safety
The Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) combines the functions of all the offices within Center for Devices and Radiological Health (CDRH) into one organizational unit for cradle-to-grave regulation of in vitro diagnostic devices (IVDs).
- Compliance Activities - GMP / QSR
Provides documents to assist medical device manufacturers with GMP/QSR compliance.
- CDRH Ombudsman
Investigates complaints from outside FDA, and facilitates the resolution of disputes between CDRH and the industry it regulates.
- Device Advice
CDRH`s self-service site for medical device and radiation emitting product information. Device Advice is an interactive system obtaining information concerning medical devices.
- Medical Device Quality Systems Manual: A Small Entity Compliance Guide
Covers the Quality System regulation and the basic Good Manufacturing Practices (GMP) requirements that all manufacturers and distributors must consider when they plan to manufacture medical devices, including medical device kits, trays or packs, for distribution in the United States. Model procedures and sample forms are also included in the manual to assist manufacturers.
- Medical Device User Fee and Modernization Act of 20
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-250, amends the Federal Food, Drug, and Cosmetic Act to provide FDA important new responsibilities, resources, and challenges.User fees for premarket reviews;establishment inspections may be conducted by accredited persons (third-parties);new regulatory requirements for reprocessed single-use devices. This site contains information on MDUFMA.
- CDRH Learn Course List< Provides information and links to online courses CDRH currently offers.
Medical Device Quick Regulatory Questions:
Radiation Emitting Products Quick Regulatory Questions:
Last Update: 19 September 2011
Indicates content available to ISPE members only.