The “Device History Record”.The Device History Record (DHR) is outlined in the US FDA Quality System Requirements, Part 820, section 184. The FDA mandates that every manufacturer of a medical device maintains a DHR. To support the effective implementation of a DHR process, there needs to be approved procedures in place within the manufacturing organization. DHR’s need to be maintained for every batch, lot or unit processed. The DHR’s will be required to demonstrate that the devices produced comply with the details of the applicable Device Master Record.
The FDA define certain minimum information which need to be retained within the DHR, namely:
The manufactured date(s),
The quantity manufactured,
The quantity released for distribution to the market,
The test and acceptance records, which need to show that the devices comply with the requirements of the Device Master Record,
Details of the labels applied to the devices, (hard copy sample of the exact labels are a good idea)
Details of any unique device identifiers (UDI’s) or universal product codes (UPC’s) or other relevant device identification numbers.
TITLE 21–FOOD AND DRUGS – CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES – SUBCHAPTER H–MEDICAL DEVICES
Sec. 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]
- Validation. Classification. Regulation. Requirements. Current best practices.
- FDA cGMP’s. EU MDR’s / MDD’s.
- FDA Medical Device Regulation.
- FDA Medical Device Classification.
- EU Medical Device Regulation and Classification (per MDD’s).
- European Medical Device Regulations (MDR’s).
- Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
- Quality System requirements to maintain compliant Validations.
- Medical Device Process Validation. IQ. OQ. PQ’s.
- Medical Device Software Validation.
- Medical Device Design Validation.
- Electronic Signature, Electronic Records.
- Life Cycle Approach to Validation.
- Risk Identification. Documentation. DHR’s. DMR’s.
- Etc. Etc. …
- The Principles & Practices of Medical Device & MedTech Validation >>>