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U.S. Department of Health and Human Services

Medical Devices

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510(k) Frequently Asked Questions

Distributors
Foreign Manufacturers
Registration
Quality System

 Distributors

I would like to distribute a manufacturer's product under my own company name. Do I need to submit a 510(k)?

No, the manufacture should submit the 510(k), if required for the device. As required under 21 CFR 801.1(c), where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such device; such as, "Manufactured for ABC Company," "Distributed by ABC Company," or any other wording that expresses the facts.

The distributor should forward all product complaints to the manufacturer for evaluation in accordance with 21 CFR 820.198 Complaint files.

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 Foreign Manufacturers

Can foreign companies submit a Premarket Notification 510(k)?

Yes. The foreign manufacturer may submit a 510(k) directly to FDA. For convenience, a foreign manufacturer may receive assistance from a U.S. entity and may use a contact person residing in the U.S.

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 Registration

Do I need to register my facility before I submit a 510(k)?

No. If you are a new company and do not manufacture any medical devices, you should not register until you are within 30 days of manufacturing and distributing the device. The 510(k) submission should state that you are not currently registered. Information on how to register your facility is available at Registering Your Establishment.

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 Quality System

Do I need to provide documentation that my facility complies with the Quality System in my 510(k)?

No. However, if you are submitting a Special 510(k), you must provide declaration of conformity with the design controls aspect of the Quality System.

Do I need to have my facility inspected to the Quality System regulations before I submit a 510(k)?

No. There is no pre-approval inspection as a prerequisite to 510(k) clearance. However, you should be prepared for an FDA inspection at any time.

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