# 21 C.F.R. § 807.90 (2026): Format of a premarket notification submission

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P807_S807_90

## Section

- **Citation:** 21 C.F.R. § 807.90 (2026)
- **Heading:** Format of a premarket notification submission
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 21 CFR: Food and Drugs / Chapter I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES / Part 807: ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES / Subpart E: Premarket Notification Procedures / § 807.90: § 807.90   Format of a premarket notification submission.

## Text

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.
[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]

## Nearby sections

- [21 C.F.R. § 807.81 (2026) § 807.81   When a premarket notification submission is required.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P807_S807_81.md)
- [21 C.F.R. § 807.85 (2026) § 807.85   Exemption from premarket notification.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P807_S807_85.md)
- [21 C.F.R. § 807.87 (2026) § 807.87   Information required in a premarket notification submission.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P807_S807_87.md)
- [21 C.F.R. § 807.90 (2026) § 807.90   Format of a premarket notification submission.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P807_S807_90.md)
- [21 C.F.R. § 807.92 (2026) § 807.92   Content and format of a 510(k) summary.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P807_S807_92.md)
- [21 C.F.R. § 807.93 (2026) § 807.93   Content and format of a 510(k) statement.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P807_S807_93.md)
- [21 C.F.R. § 807.94 (2026) § 807.94   Format of a class III certification.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P807_S807_94.md)
- [21 C.F.R. § 807.95 (2026) § 807.95   Confidentiality of information.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P807_S807_95.md)
- [21 C.F.R. § 807.97 (2026) § 807.97   Misbranding by reference to premarket notification.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P807_S807_97.md)
- [21 C.F.R. § 807.100 (2026) § 807.100   FDA action on a premarket notification.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P807_S807_100.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P807_S807_90. Check the current official text before relying on it. Not legal advice.