21 CFR Part 830
Administrative practice and procedure, Incorporation by reference, Labeling, Medical devices, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
PART 16--REGULATORY HEARING BEFORE THE
1. The authority citation for 21 CFR part 16 continues to read as follows:
Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.
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(b) * * *
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SEC 830.130, relating to suspension or revocation of the accreditation of an issuing agency.
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3. The authority citation for 21 CFR part 801 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.
4a. Add new
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
Combination product has the meaning set forth in
Convenience kit means two or more different medical devices packaged together for the convenience of the user.
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
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 cells, tissues, or cellular or tissue-based product (HCT/P) regulated as a device means an HCT/P as defined in
Implantable device means a device that is intended to be placed in a surgically or naturally formed cavity of the human body. A device is regarded as an implantable device for the purpose of this part only if it is intended to remain implanted continuously for a period of 30 days or more, unless the Commissioner of Food and Drugs determines otherwise in order to protect human health.
Label has the meaning set forth in section 201(k) of the Federal Food, Drug, and Cosmetic Act.
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