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FDA Registration

Certain business activities require facility registration with the U.S. Food and Drug Administration.

Businesses that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. Dental laboratories and manufacturers of dental materials and equipment may be required to register based upon the devices that they manufacture and distribute.

Domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are required to register with FDA biennially. Breweries are considered to be food manufacturers and therefore must register with FDA prior to initiating the brewing activities.

SafeLink’s FDA consultants can help determine if registration with FDA is required for your business activities and guide you through the FDA registration process. SafeLink Consulting is ready to help you achieve compliance. Contact us to learn more. Get assistance in developing your Quality Management System. Get assistance with FDA 510k submission.

Contact us to learn more.

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Does my business have to register with FDA?
(Dental Regulations)

About Safelink Consulting

SafeLink presenters are nationally recognized for providing workshops and seminars to diverse audiences. Through onsite visits, seminars, and Webinars SafeLink’s presenters have successfully trained thousands of our clients’ employees on safety and quality management.

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