---
kind: "section"
citation: "21 C.F.R. § 807.90"
title: "21"
number: "807.90"
heading: "Format of a premarket notification submission."
url: "https://uscodex.org/cfr/21/807.90"
---

# §807.90. Format of a premarket notification submission.


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 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.
- (b) [Reserved]
- (c) **Be submitted as 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.**

## Notes

### Amendments

[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]

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360e-4, 360i, 360j, 360bbb-8b, 371, 374, 379k-1, 381, 393; 42 U.S.C. 264, 271.

### Source

Source: 42 FR 42526, Aug. 23, 1977, unless otherwise noted.

### Amendments

[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]