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Assistance for small manufacturers and other domestic
and foreign producers of medical devices and radiation-emitting electronic
products
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Answering Questions |
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.
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