21 CFR 820.184 - Device history record.

§ 820.184 Device history record.

Each manufacturer shall maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures to ensure that DHR's for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part. The DHR shall include, or refer to the location of, the following information:

(a) The dates of manufacture;

(b) The quantity manufactured;

(c) The quantity released for distribution;

(d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR;

(e) The primary identification label and labeling used for each production unit; and

(f) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used.

[ 61 FR 52654, Oct. 7, 1996, as amended at 78 FR 58822, Sept. 24, 2013]

Title 21 published on 19-May-2018 03:57

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 820 after this date.

  • 2018-01-16; vol. 83 # 10 - Tuesday, January 16, 2018
    1. 83 FR 2057 - Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff; Availability
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notification of availability.
      The announcement of the guidance is published in the Federal Register on January 16, 2018.
      21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830