Source: https://www.emergobyul.com/resources/regulations-united-states/21-cfr-821
Timestamp: 2019-11-15 07:31:06
Document Index: 737741352

Matched Legal Cases: ['art 821', 'ART 821', '§ 821', '§ 821', '§ 821', '§ 821', '§ 821', '§ 821', '§ 821', '§ 821', '§ 821', '§ 821', 'art 812']

US FDA Quality System Regulation (QSR) – 21 CFR Part 821
PART 821 MEDICAL DEVICE TRACKING REQUIREMENTS
§ 821.1 - Scope.
§ 821.2 - Exemptions and variances.
§ 821.2 - Definitions.
§ 821.4 - Imported devices.
§ 821.20 - Devices subject to tracking.
§ 821.25 - Device tracking system and content requirements: manufacturer requirements.
§ 821.30 - Tracking obligations of persons other than device manufacturers: distributor requirements.
§ 821.50 - Availability.
§ 821.55 - Confidentiality.
§ 821.60 - Retention of records.
(j) Distributes means any distribution of a tracked device, including the charitable distribution of a tracked device. This term does not include the distribution of a device under an effective investigational device exemption in accordance with section 520(g) of the act and part 812 of this chapter or the distribution of a device for teaching, law enforcement, research, or analysis as specified in 801.125 of this chapter.
(n) 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) of this chapter that does not meet the criteria in 1271.10(a) and that is also regulated as a device.
[58 FR 43447, Aug. 16, 1993, as amended at 67 FR 5951, Feb. 8, 2002; 78 FR 55822, Sept. 24, 2013]