Center for Devices and Radiologic Health

General medical devices are the responsibility of the Center for Devices and Radiological Health (CDRH). The CDRH is also responsible for assessing the safety of non-medical radiation-emitting products such as televisions, microwaves and mobile telephones. 

The regulation of medical devices in the U S was introduced with the Medical Device Amendments to FDC Act in 1976. These are supported by regulations published in 21 CFR parts 800-899. The Center for Devices and Radiological Health (CDRH) is the responsible section within the FDA for regulation of devices. 

Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products. Center for Devices and Radiologic Health, FDA, Rockville, MD, 1997. 

The Safe Medical Devices Act of 1990, a major revision to the 1976 amendments, among other revised requirements provided two major mechanisms for bringing an IVD medical device to market premarket notification and premarket approval. The act is administered by the FDA s Center for Devices and Radiological Health, of which the Division of Clinical Laboratory Devices (DCLD) is a part. The premarket notification process is used for devices that can be classified... 

A small number of biotechnology products are classified as medical devices and, hence, are regulated by the Center for Devices and Radiological Health (CDRH). The first approved biotech product to come under the auspices of the CDRH was OP-1 implant. Marketed by Stryker Biotech, OP-1 implant is a sterile powder composed of recombinant human oestrogenic protein-1 (OP-1) along with bovine collagen. It is used to treat fractured bones that fail to heal. The product is mixed with sterile saline immediately before application, and entails surgical insertion of the paste into the fracture. 

Steven I. Gutman, M.D., Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD... 

E. Medical Device Reporting. The manufacturers, distributors, importers, and users of all devices, including those regulated by CDER, shall report to CDRH under Section 519 of the Act as required. The Center for Devices and Radiological Health will provide monthly reports and special reports as needed to CDER for investigation and follow-up of those medical devices regulated by CDER. 

In June 1993, the Center for Devices and Radiological Health (CDRH) introduced tier/triage management initiatives to improve the efficiency of its administrative and scientific review of premarket applications. One key item in this plan was introduction of a tier/triage process for 510(k) applications. This proposal was designed to allow levels of 510(k) reviews adjusted according to the device risk. Three review levels were proposed as follows ... 

US FDA (2001) Safety assessment of di(2-ethylhexyl) phthalate (DEHP) released from PVC medical devices. Center for Devices and Radiological Health, U.S. Food and Drug Administration, Rockville, http //www.fda.gov/cdrh/ost/dehp-pvc.pdf... 

A small number of biotechnology products are classified as medical devices and hence are regulated by the Center for Devices and Radiological Health. The first approved biotech product to come under the auspices of the CDRH was OP-1 implant. Marketed by Stryker... 

FDA, Review Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review, Office of Device Evaluation Center for Devices and Radiological Health, 1991. 

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