---
kind: "section"
citation: "21 C.F.R. § 1.76"
title: "21"
number: "1.76"
heading: "Medical devices."
url: "https://uscodex.org/cfr/21/1.76"
---

# §1.76. Medical devices.


In addition to the data required to be submitted in [§ 1.72](/cfr/21/1.72.md), an ACE filer must submit the following information at the time of filing entry in ACE for medical devices regulated by the FDA Center for Devices and Radiological Health.

- (a) **Registration and listing.** For a medical device, the Registration Number for Foreign Manufacturers, Foreign Exporters, and/or Domestic Manufacturers, and the Device Listing Number, required under [section 510](/cfr/21/510.md) of the Federal Food, Drug, and Cosmetic Act and [part 807](/cfr/21/part807.md) of this chapter.
- (b) **Investigational devices.** For an investigational medical device that has an investigational device exemption granted under [section 520(g)](/cfr/21/520.md?p=g) of the Federal Food, Drug, and Cosmetic Act, the Investigational Device Exemption Number. For an investigational medical device being imported or offered for import for use in a nonsignificant risk or exempt study, “NSR” to be entered in the Affirmation of Compliance for the “investigational device exemption” that identifies the device as being used in a nonsignificant risk or exempt study.
- (c) **Premarket number.** For a medical device that has one, the Premarket Number. This is the Premarket Approval Number for those medical devices that have received premarket approval under [section 515](/cfr/21/515.md) of the Federal Food, Drug, and Cosmetic Act; the Product Development Protocol Number for those medical devices for which FDA has declared the product development protocol complete under [section 515(f)](/cfr/21/515.md?p=f) of the Federal Food, Drug, and Cosmetic Act; the De Novo number for those medical devices granted marketing authorization under [section 513(f)(2)](/cfr/21/513.md?p=f-2) of the Federal Food, Drug, and Cosmetic Act; the Premarket Notification Number for those medical devices that received premarket clearance under [section 510(k)](/cfr/21/510.md?p=k) of the Federal Food, Drug, and Cosmetic Act; or the Humanitarian Device Exemption Number for those medical devices for which an exemption has been granted under [section 520(m)](/cfr/21/520.md?p=m) of the Federal Food, Drug, and Cosmetic Act.
- (d) **Component.** If applicable for a medical device, an affirmation identifying that the article being imported or offered for import is a component that requires further processing or inclusion into a finished medical device.
- (e) **Lead wire/patient cable.** For electrode lead wires and patient cables intended for use with a medical device, an Affirmation of Compliance with the applicable performance standard under [§ 898.12](/cfr/21/898.12.md) of this chapter.
- (f) **Impact resistant lens.** For impact resistant lenses in eyeglasses and sunglasses, an Affirmation of Compliance with the applicable requirements of [§ 801.410](/cfr/21/801.410.md) of this chapter.
- (g) **Convenience kit.** If applicable for a medical device, an Affirmation of Compliance that the article imported or offered for import is a convenience kit or part of a convenience kit.

## Notes

### Source

Source: 81 FR 85870, Nov. 29, 2016, unless otherwise noted.

### Authority

Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271.

### Source

Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.