Center for Device and Radiological Health CDRH

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. 

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. 

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 ... 

Center for Drug Evaluation and Research (CDER), Center for Biologies Evaluation and Research (CBER). Guidance for Industry, Center for Devices and Radiological Health (CDRH). Draft Guidance for Industry Financial Disclosure by Clinical Investigators, Oct. 26, 1999. 

Center for Devices and Radiological Health (CDRH), Medical Device Reporting for Manufacturers, March 1997. 

We recommend that you submit your annual report and post-approval study report separately, even if they are due at the same time. This will facilitate the FDA s review because different Offices in Center for Devices and Radiological Health (CDRH) review the post-approval study report and the annual report.5 If you choose to provide a separate report as recommended, please include the date that you submitted your post-approval study report in your annual report. 

Once a Sponsor determines that their product fits one of the definitions of a combination product, the sponsor then must determine the lead Center within the FDA that will assume regulatory responsibility for the product. This determination is made by considering the primary mode of action (PMOA) [4] of the product. In simple terms, if the main function of the product is a device function, then it is likely that the Center for Devices and Radiological Health (CDRH) will have primary responsibility for the product. On the other hand, either the Center for Biologies Evaluation (CBER) or the Center for Drug Evaluation and Research (CDER) will be assigned primary review responsibility based on whether the PMOA of the product is dependent on... 

U. S. Food and Drug Administration, Center for Device and Radiological Health (CDRH) Web site, www.fda.gov/cdrh/devadvice/313.html. Accessed December 15, 2006. 

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