(e) Remain in compliance with the eligibility and accreditation criteria set forth in
FDA may suspend or revoke the accreditation of an issuing agency if
(a) Has been guilty of misrepresentation or failure to disclose required information in obtaining accreditation;
(b) Has failed to fulfill the responsibilities outlined in
(c) Has failed to protect against conflicts of interest that may impede the issuing agency's ability to independently operate a fair and neutral identifier system;
(d) In the operation of the issuing agency, has engaged in any anticompetitive activity to restrain trade; or
(e) Has violated or aided and abetted in the violation of any regulation issued under section 510(e) or section 519(f) of the Federal Food, Drug, and Cosmetic Act.
Subpart A--General Provisions
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
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
Federal Food, Drug, and Cosmetic Act means 21 U.S.C.
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 tissue-based product (HCT/P) regulated as a device means an HCT/P as defined in
Issuing agency means an organization accredited by
Label has the meaning set forth in section 201(k) of the Federal Food, Drug, and Cosmetic Act.
(1) Any person who causes a label to be applied to a device with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label; and
(2) Any person who causes the label of a device to be replaced or modified with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label, except that the addition of the name of, and contact information for, a person who distributes the device, without making any other changes to the label, is not a modification for the purposes of determining whether a person is a labeler.
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