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Medicine and Public Policy |

Medical Device Regulation: An Introduction for the Practicing Physician

William H. Maisel, MD, MPH
[+] Article, Author, and Disclosure Information

From Brigham and Women's Hospital, Boston, Massachusetts.

Disclaimer: The opinions expressed in this paper are those of the author and do not necessarily reflect the opinion of the U.S. Food and Drug Administration.

Potential Financial Conflicts of Interest:Consultancies: U.S. Food and Drug Administration Center for Devices and Radiologic Health and Circulatory Systems Device Panel of the Medical Devices Advisory Committee.

Requests for Single Reprints: William H. Maisel, MD, MPH, Cardiovascular Division, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115; e-mail, wmaisel@partners.org.

Ann Intern Med. 2004;140(4):296-302. doi:10.7326/0003-4819-140-4-200402170-00012
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Patient care for the practicing physician increasingly relies on medical devices. The U.S. Food and Drug Administration is responsible for the safety and effectiveness of medical devices in the United States. In addition to playing a role in the clinical use of devices, physicians may also participate in their design, production, use, and safety by expressing their need for certain products, by providing practical input and feedback into product design, by participating in device-related research, and by reporting device-related adverse events. Physicians should understand the rules that govern the approved and unapproved use of medical devices as well as device premarket evaluation and approval processes and device postmarket surveillance.


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Overview of the medical device approval process.

Some medical devices are perceived to be low risk and are exempt from close scrutiny by the U.S. Food and Drug Administration (FDA). In some cases, the device's manufacturer need only demonstrate compliance with Good Manufacturing Practices and then register and list the device with the FDA. Medium-risk devices that have the same intended use and same technological characteristics as a previously approved, legally marketed product are considered “substantially equivalent” to this “predicate” device and may be evaluated with a 510(k) application. This application requires demonstration that the predicate device is safe and effective and that the new device raises no new questions of safety or effectiveness. The FDA mandates the more comprehensive Premarket Approval Application for certain higher-risk devices or devices that raise new questions of safety or effectiveness. Investigational devices undergoing clinical study require an Investigational Device Exemption if they potentially pose a “significant risk” to the patient.

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