scope:

Definitions.

As used in this part:

Automatic identification and data capture (AIDC) means any technology that conveys the unique device identifier or the device identifier of a device in a form that can be entered into an electronic patient record or other computer system via an automated process.

Center Director means the Director of the Center for Devices and Radiological Health or the Director of the Center for Biologics Evaluation and Research, depending on which Center has been assigned lead responsibility for the device.

Device package means a package that contains a fixed quantity of a particular version or model of a device.

Expiration date means the date by which the label of a device states the device must or should be used.

FDA, we, or us means the Food and Drug Administration.

Federal Food, Drug, and Cosmetic Act means 21 U.S.C. 321 et seq., as amended.

Finished device means any device or accessory to any device that is suitable for use or capable of functioning.

Global Unique Device Identification Database (GUDID) means the database that serves as a repository of information to facilitate the identification of medical devices through their distribution and use.

Human cell, tissue, or cellular or tissuebased product (HCT/P) regulated as a device means an HCT/P as defined in § 1271.3(d) of this chapter that does not meet the criteria in § 1271.10(a) and that is also regulated as a device.

Issuing agency means an organization accredited by FDA to operate a system for the issuance of unique device identifiers.

Label has the meaning set forth in section 201(k) of the Federal Food, Drug, and Cosmetic Act.