(e) Control number. FDA Registration Number and other FDA Requirements Manufacturers and distributors who plan to market their products in the USA most often recognize that FDA registration number is a mandatory requirement, but most of them are not aware of other FDA requirements like, GMP, listing, label compliance, UDI, prior notice, etc. Medical Devices Databases A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval. The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. Sec. FDA: Protect Your Family From Fraudulent Flu Products **Hand Sanitizer, Drug Recalls and Safety Alerts Updated 12/24/2020** Hand Sanitizer Advisory (PDF) FDA Alert: An Increased Risk of a False Positive Result with BD SARS-CoV-2 Reagentsfor the BD Max System Test Where a control number is required by § 820.65, that control number shall be on or shall accompany the device through distribution. Free online tool to check Thai FDA number approval and registration statuses. Receive all necessary information about Thai FDA Number just in few clicks. I have some devices stuck at the American Customs and are asking for the following numbers. Specify required products type from the following list: Food, Medicine, Drugs, Cosmetics, Medical device or Dangerous goods. The FDA also provides accurate, science-based health information to the public. Enter the existing Thai FDA Number in the search field. The FDA Office of Regulatory Affairs Columbus, located in Columbus, OH, is a branch location of the U.S. Food and Drug Administration (FDA). Liberty Management Group Ltd. assists domestic and foreign food, drug, medical device and cosmetic manufacturing companies to register with US FDA. The focus of these controls is to ensure that labels are accurately designed and properly applied to the correct products. The U.S. Food and Drug Administration (FDA) requires that all registered food, medical device, and drug facilities renew their FDA registration between October 1 and December 31, Renew Now Notice [61 FR 52654, Oct. 7, 1996, as amended at 78 FR 58822, Sept. 24, 2013] - - FDA: Face Masks, Including Surgical Masks, and Respirators for COVID-19. (a) The label of a device in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor. 801.1 Medical devices; name and place of business of manufacturer, packer or distributor. 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