Medical Device FDA Facility (Business) Registration Medical Device U.S. FDA Facility (Business) Registration
According to the U.S. Code of Federal Regulations, 21 CFR part 807, companies involved in the manufacture and distribution of medical devices for commercial distribution in the United States are required to register annually with the U.S. Food and Drug Administration (FDA). The registration process is called Establishment Registration; at the same time, these companies must identify to the FDA the medical devices they distribute commercially, including those for export only, in a process called Medical Device Listing.
Effective February 11, 2002, all firms outside the United States must designate a U.S. agent (US AGENT) contact information to the FDA at the time of factory registration.
For information about the US AGENT please click --> US AGENT INFORMATION NOTE: According to FDA regulations, only the US AGENT is required to be located in the United States. Any organization or individual not located in the United States can not directly provide U.S. FDA authorized agent services. Please be careful to identify them.
If a company exporting a U.S. medical product does not have an updated and active registration, the import declaration will be required by the FDA to withdraw from the market, so please note whether your company's registration is currently ACTIVE.
FDA application, need to pay attention to the following issues:
1, before the application must be clear whether the product is recognized by the FDA as a medical device, product categories, management requirements, clear application work;
2, the application for the listing of the product to check whether there is a U.S. mandatory standards, the product whether it is in line with the standard (generally require the testing agency's official inspection report);
3, in the preparation of 510 (K) application before the document, you need to consider whether you really need to submit, when to submit and submit which nature of the 510 (K) application: regular 510 (K), special 510 (K), simplified 510 (K);
4, the application process FDA questions should be given in writing in time to give timely answers;
5, the application to FDA to see if there is a U.S. mandatory standard, the product meets the standard (generally require formal inspection reports from testing organizations). p>5, all information submitted to the FDA paper size should be used Letter Size (21.5cm × 29.7cm);
6, all the information submitted to the FDA enterprises need to keep a backup, because the FDA in the receipt of application information that is electronically scanned after logging in, and at the same time, the destruction of the application information, and does not return to the enterprise.
7, for a small number of products, the FDA will be on-site GMP assessment of enterprises, enterprises need to refer to the U.S. GMP management requirements, and in the FDA on-site audit is equipped with a suitable, on GMP and business have a certain understanding of the interpreter;
8, informed the FDA's official contact person needs to be a certain understanding of the FDA regulations and work procedures, and can be directly communicated with FDA, in order to facilitate timely feedback, the enterprises will not be able to provide any information to the FDA, the FDA will not be able to provide any information to the enterprises. communication, in order to facilitate timely feedback, the enterprise can specify their own or entrust the consulting organization responsible for daily communication with the FDA.
Not updated registration will fda notice: We are writing to you concerning your firm's obligation to submit annual registration and listing information to the Food and Drug Administration (FDA). Administration (FDA). Under section 510(b)(2) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. §360(b)(2), your firm is required to submit annual registration information for each establishment that it owns. information for each establishment that it owns or operates that is engaged in the manufacture, preparation, propagation, compounding, or processing of a device. In addition, under section 510(j)(2) of the Act, 21 U.S.C. § 360(j)(2), your firm is required to annually report a list identifying each device that it introduces for commercial distribution that has the capacity to be used in the manufacture, preparation, propagation, compounding, or processing of a device. that it introduced for commercial distribution that has not been included in any list previously filed with FDA, as well as any material change to Your firm is required to annually report a list identifying each device that it introduced for commercial distribution that has not been included in any list previously filed with FDA, as well as any material change to information previously submitted and other information. Your firm is required to submit annual registration and listing information during the period beginning on October 1 and ending on December 31. As you may know, in September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110-85) to require each person to submit annual registration and listing information during the period beginning on October 1 and ending on December 31. 110-85) to require each person who is subject to registration and listing requirements to submit annual establishment registration and device listing information to FDA by electronic means (Pub. L. 110-85). information to FDA by electronic means (section 510(p) of the Act, 21 U.S.C. §360(p). Thus, your firm must register and list electronically unless it can show that using the Internet to register is not reasonable for it and FDA grants its request for a waiver.