---
kind: "section"
citation: "21 C.F.R. § 807.85"
title: "21"
number: "807.85"
heading: "Exemption from premarket notification."
url: "https://uscodex.org/cfr/21/807.85"
---

# §807.85. Exemption from premarket notification.

- (a) A custom device is exempt from premarket notification requirements of this subpart if the device is within the meaning of [section 520(b)](/cfr/21/520.md?p=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.**

## Notes

### Amendments

[42 FR 42526, Aug. 23, 1977, as amended at 81 FR 70340, Oct. 12, 2016]

### 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 81 FR 70340, Oct. 12, 2016]