FDA Compliance Help Desk, Inc.
Establishments involved in the production and distribution of medical devices intended for marketing or leasing (commercial distribution) in the United States (U.S.) are required to register with the FDA. This process is known as establishment registration. Registration provides FDA with the location of medical device manufacturing facilities and importers. The regulations for establishment registration are provided in 21 CFR 807. A registration fee is also required. An establishment means any place of business under one management at one physical location at which a device is manufactured, assembled or otherwise processed for commercial distribution. The "owner/operator" of the establishment is responsible for registration. Owner/operator means the corporation, subsidiary, affiliated company, partnership, or proprietor directly responsible for the activities of the registering establishment. Registration of an establishment is not an approval of the establishment or its devices by FDA. That is, it does not provide FDA clearance to market. Unless exempt, premarketing clearance is required before a device can be placed into commercial distribution in the U.S. http://www.fda.gov/cdrh/devadvice/341.html#link_1
Firms manufacturing drug products must register the site where the product was made within 5 days of commercial distribution. Annually, firms must re-register, updating and validating current site information as required by Section 510 of the Federal Food, Drug, and Cosmetic Act and the Code of Federal Regulations 21 CFR part 207. Refer to Draft Guidance for Industry Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution for additional background information. Refer to Draft Guidance for Industry Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution for additional background information. The forms are processed within 60-90 days. You may not see your site Current Registration annual year updated for several weeks. Firms submitting Form FDA 2656 to satisfy their annual re-registration requirement will not receive immediate written confirmation of the submission. The validated copy of the submission will be mailed to the firm within 30 to 90 days after receipt of form by FDA.
FDA Compliance Help Desk, Inc. is a specialized FDA regulatory compliance consulting firm serving the needs of medical device firms, human and veterinary drug firms, and biological product firms.
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Last modified: December 3, 2008
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