§ 807.90 - Format of a premarket notification submission.

§ 807.90 Format of a premarket notification submission.

Cross Reference

Link to an amendment published at 84 FR 68339, Dec. 16, 2019.

Each premarket notification submission pursuant to this part shall be submitted in accordance with this section. Each submission shall:

(a)

(1) For devices regulated by the Center for Devices and Radiological Health, be addressed to the Food and Drug Administration, Center for Devices and Radiological Health, Document Mail Center, 10903 New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993-0002. 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 Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002current 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 by using the Center for Biologics Evaluation and Research electronic Web-based application on the Internet. at https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/default.htm.

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

(b) Be bound into a volume or volumes, where necessary. [Reserved]

(c) Be submitted in duplicate on standard size paper, including the original and two copies of the cover letteras a single version in electronic format.

(d) Be submitted separately for each product the manufacturer intends to market.

(e) Designated “510(k) Notification” in the cover letter.

[42 FR 42526, Aug. 23, 1977, as amended at 53 FR 11252, Apr. 6, 1988; 55 FR 11169, Mar. 27, 1990; 65 FR 17137, Mar. 31, 2000; 70 FR 14986, Mar. 24, 2005; 75 FR 20915, Apr. 22, 2010; 80 FR 18094, Apr. 3, 2015; 84 FR 68339, Dec. 16, 2019]