Medical devices Radiological Health

Foods Human Drugs Biologies Animal Drugs Cosmetics Medical Devices/Radiological Health... 

Parts 800 to 1299. Medical devices and radiological health. Regulations under the Federal Import Milk Act, the Federal Tea Importation Act, the Federal Caustic Poison Act, and for control of communicable diseases and interstate conveyance sanitation. 

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. 

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. 

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. 

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. 

The three product centers that can lead the regulatory review of a neoorgan product include Center for Devices and Radiological Health (CDHR), Center for Biologies Evaluation and Research (CBER), and the Center for Drug Evaluation Research (CDER). CDRH is responsible for regulating those products that are primarily medical devices. A medical device is defined as An instrument, apparatus, implement, machine, contrivance, implant, or other similar or related article, including a component, part, or accessory,... 

PDA (1999), Off-The-Shelf Software Use in Medical Devices, PDA 1252, U.S. Department of Health and Human Services, Pood and Drug Administration, Center for Devices and Radiological Health, September 9. 

Medical devices are regulated by the Food, Drug, and Cosmetic Act, the Center for Devices and Radiological Health, and the Office of Device Regulation. Device classification <[Pg.45]

On the national level, oversight is generally restricted to medical devices, and not on operational matters. Federal jurisdiction of medical devices falls under the purview of the Department of Health and Human Services, Public Health Service, Food and Drug Administration (FDA), Center for Devices and Radiological Health. Under federal law, medical devices are regulated under the Medical Device Amendments of 1976 and the Radiation Control for Health and Safety Act of 1968. Additional regulatory authorization is provided by the Safe Medical Devices Act of 1990, the Medical Device Amendments of 1992, the FDA Reform and Enhancement Act of 1996, and the Food and Drug Administration Modernization Act of 1997. ... 

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