- The FDA does not “certify" devices, and the FDA logo is for the official use of the FDA and not for use on private sector materials. The FDA does not issue registration certificates to medical device facilities nor does the FDA certify information for facilities that have registered their establishments and listed their medical devices. When a facility registers and lists its devices, the resulting entry in FDA’s registration and listing database does not denote approval, clearance or authorization of that facility or its medical devices.
- All device establishments required to register must complete their annual registration for each Fiscal Year between October 1 and December 31.
- FDA is aware that various firms may be offering their services to assist domestic and/or foreign facilities to register with FDA. Please note that these firms are not affiliated with FDA, nor has the agency contracted with any firms to register facilities. FDA does not use any outside contractors to notify or bill regulated industry about the need to register. FDA does not require firms to hire someone to complete the on-line registration process.
- FDA is aware that some browsers and equipment may not operate correctly with our system. These include MAC personal computers, Internet Explorer 8.0, wide screen monitors, and browsers such as Firefox or Google browser (CHROME).
- FDA communicates with registered medical device establishments by email. In order to receive electronic communications from FDA, be sure to set your spam filters to accept email from any @fda.gov, @cdrh.fda.gov, or @fda.hhs.gov email address.
- In completing product listings for facilities, bear in mind that you are required to identify any that are combination products. If you are uncertain whether a product is a device or a combination product, information is available at https://www.fda.gov/combination-products/about-combination-products/combination-product-definition-combination-product-types, or you may contact the FDA’s Office of Combination Products at firstname.lastname@example.org for assistance.