# 21 C.F.R. § 807.85 (2026): Exemption from premarket notification

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P807_S807_85

## Section

- **Citation:** 21 C.F.R. § 807.85 (2026)
- **Heading:** Exemption from premarket notification
- **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 / § 807.85: § 807.85   Exemption from premarket notification.

## Text

(a) A custom device is exempt from premarket notification requirements of this subpart if the device is within the meaning of section 520(b) of the Federal Food, Drug, and Cosmetic Act.
(1) It is intended for use by a patient named in the order of the physician or dentist (or other specially qualified person); or
(2) It is intended solely for use by a physician or dentist (or other specially qualified person) and is not generally available to, or generally used by, other physicians or dentists (or other specially qualified persons).
(b) A distributor who places a device into commercial distribution for the first time under his own name and a repackager who places his own name on a device and does not change any other labeling or otherwise affect the device shall be exempted from the premarket notification requirements of this subpart if:
(1) The device was in commercial distribution before May 28, 1976; or
(2) A premarket notification submission was filed by another person.
[42 FR 42526, Aug. 23, 1977, as amended at 81 FR 70340, Oct. 12, 2016]

## 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_85. Check the current official text before relying on it. Not legal advice.