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U.S. Department of Health and Human Services

Medical Devices

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Answering Questions

The Division of Small Manufacturers, International and Consumer Assistance (DSMICA) was mandated by the 1976 medical device legislation to provide technical and regulatory assistance to small manufacturers to help them comply with Food and Drug Administration (FDA) requirements for medical devices. Promulgation of the Safe Medical Devices Act of 1990 and the FDA Modernization Act of 1997 have also expanded DSMICA's role in providing regulatory assistance.

Small Manufacturers Assistance Staff
The manufacturers staff provides regulatory assistance to medical device manufacturers and to manufacturers of electronic products which emit radiation. Assistance includes product classification, premarket and postmarket requirements, labeling, manufacturing requirements (quality system), and import/export issues for medical devices and reporting requirements for electronic products.

Consumer Staff
The consumer provides information to consumers regarding medical devices and radiation-emitting products to enhance their ability to avoid risk, achieve maximum benefit, and make informed decisions about the use of such products.

International Affairs Staff
The international affairs staff identifies and supports global harmonization activities, educates foreign governments on the United States (U.S.) medical device regulatory process, and directs U.S. firms to sources of information on foreign requirements for medical devices.