---
kind: "section"
citation: "21 C.F.R. § 810.2"
title: "21"
number: "810.2"
heading: "Definitions."
url: "https://uscodex.org/cfr/21/810.2"
---

# §810.2. Definitions.


As used in this part:

- (a) Act means the Federal Food, Drug, and Cosmetic Act.
- (b) **Agency—** or FDA means the Food and Drug Administration.
- (c) **Cease distribution and notification strategy—** or mandatory recall strategy means a planned, specific course of action to be taken by the person named in a cease distribution and notification order or in a mandatory recall order, which addresses the extent of the notification or recall, the need for public warnings, and the extent of effectiveness checks to be conducted.
- (d) Consignee means any person or firm that has received, purchased, or used a device that is subject to a cease distribution and notification order or a mandatory recall order. Consignee does not mean lay individuals or patients, i.e., nonhealth professionals.
- (e) Correction means repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device, without its physical removal from its point of use to some other location.
- (f) Device user facility means a hospital, ambulatory surgical facility, nursing home, or outpatient treatment or diagnostic facility that is not a physician's office.
- (g) Health professionals means practitioners, including physicians, nurses, pharmacists, dentists, respiratory therapists, physical therapists, technologists, or any other practitioners or allied health professionals that have a role in using a device for human use.
- (h) Human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device means an HCT/P as defined in [§ 1271.3(d)](/cfr/21/1271.3.md?p=d) of this chapter that does not meet the criteria in [§ 1271.10(a)](/cfr/21/1271.10.md?p=a) and that is also regulated as a device.
- (i) Reasonable probability means that it is more likely than not that an event will occur.
- (j) Serious, adverse health consequence means any significant adverse experience, including those that may be either life-threatening or involve permanent or long-term injuries, but excluding injuries that are nonlife-threatening and that are temporary and reasonably reversible.
- (k) Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death.
- (l) Removal means the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection.
- (m) Unique device identifier (UDI) means an identifier that adequately identifies a device through its distribution and use by meeting the requirements of [§ 830.20](/cfr/21/830.20.md) of this chapter. A unique device identifier is composed of:
  - (1) **A <I>device identifier</I>—** a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device; and
  - (2) **A <I>production identifier</I>—** a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device:
    - (i) The lot or batch within which a device was manufactured;
    - (ii) The serial number of a specific device;
    - (iii) The expiration date of a specific device;
    - (iv) **The date a specific device was manufactured.**
    - (v) For an HCT/P regulated as a device, the distinct identification code required by [§ 1271.290(c)](/cfr/21/1271.290.md?p=c) of this chapter.

## Notes

### Amendments

[61 FR 59018, Nov. 20, 1996, as amended at 78 FR 58821, Sept. 24, 2013]

### Authority

Authority: 21 U.S.C. 321, 331, 332, 333, 334, 351, 352, 355, 360h, 360i, 371, 374, 375.

### Source

Source: 61 FR 59018, Nov. 20, 1996, unless otherwise noted.

### Amendments

[61 FR 59018, Nov. 20, 1996, as amended at 78 FR 58821, Sept. 24, 2013]