Code of Federal Regulations Title 21. Food and Drugs § 21.807.90 Format of a premarket notification submission

(a)(1) For devices regulated by the Center for Devices and Radiological Health, be addressed to the current address displayed on the website https://www.fda.gov/cdrhsubmissionaddress.

(2) For devices regulated by the Center for Biologics Evaluation and Research, be addressed to the current address displayed on the website https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm;  or for devices regulated by the Center for Drug Evaluation and Research, be addressed to the Central Document Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901–B Ammendale Rd., Beltsville, MD 20705–1266. Information about devices regulated by the Center for Biologics Evaluation and Research is available at https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/default.htm.

(3) All inquiries regarding a premarket notification submission should be sent to the address in this section or one of the current addresses displayed on the Food and Drug Administration's website.