FDA Center for Devices and Radiological

U.S. Food and Drug Administration (FDA) (1999), Safety assessment of di-2-ethylhex-ylphthalate (DEHP) released from PVC medical devices, FDA, Center for Devices and Radiological Health, Rockville, MD. 

FDA Center for Devices and Radiological Health, Silver Spring, MD, USA... 

Andriy Matviyenko Department of Engineering, University of Maryland, College Park, MD, USA FDA Center for Devices and Radiological Health, Silver Spring, MD, USA... 

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. ... 

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... 

General Principles of Software Validation Final Guidance for Industry and FDA Staff. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Center for Biologies Evaluation and Research (2002). 

FDA ESG This document provides an overview of the process of electronic submissions and provides registration and confirmation processes as well as links to electronic submission requirements of the Center for Biologies Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Veterinary Medicine (CVM), the Adverse Events Reporting System (AERS), and the Center for Devices and Radiological Health (CDRH). 

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. 

An ISO standard, it should be noted, is a document that undergoes periodic review and is subject to revision. Recently, the FDA, more specifically the Center for Devices and Radiological Health (CDRH), has been considering the use of international consensus standards for the toxicological evaluation of medical devices. 

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