FDA Quality Record Regulation

Information & Training. | Medical Devices.

Records are critical to regulatory compliance and essential to ensure product integrity. All records need to be available to those who will need access as part of their quality impacting roles, all records which demonstrate compliance with the QSR’s must be readily retrievable. Records should be maintained for the lifetime of the medical device, at a minimum 2 years, often manufacturers retain records for 5 to 10 years beyond product life expectancy. Where the impact of the product extends beyond the lifetime of the device itself, then records should potentially be maintained for the length of time of the potential impacts, e.g. lasers used in eye surgery may have a life expectancy of 5 years, however, the impact of the laser surgery on a patient can last 50+ years.

The device master record, DMR, is seen as a critical record. The DMR needs to reference at a minimum all the device specifications, process specifications and procedures, equipment specifications, quality assurance requirements, packaging and labeling specifications, handling, distribution and installation specifications.

The device history record, DHR, again is a critical product record. The DHR needs to detail the information necessary to demonstrate that the device was manufactured to design requirements and tested to confirm product quality requirements were met.




Subpart M–Records

Sec. 820.180 General requirements.


All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of FDA designated to perform inspections. Such records, including those not stored at the inspected establishment, shall be made readily available for review and copying by FDA employee(s). Such records shall be legible and shall be stored to minimize deterioration and to prevent loss. Those records stored in automated data processing systems shall be backed up.

(a) Confidentiality. Records deemed confidential by the manufacturer may be marked to aid FDA in determining whether information may be disclosed under the public information regulation in part 20 of this chapter.

(b) Record retention period. All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer.

(c) Exceptions. This section does not apply to the reports required by 820.20(c) Management review, 820.22 Quality audits, and supplier audit reports used to meet the requirements of 820.50(a) Evaluation of suppliers, contractors, and consultants, but does apply to procedures established under these provisions. Upon request of a designated employee of FDA, an employee in management with executive responsibility shall certify in writing that the management reviews and quality audits required under this part, and supplier audits where applicable, have been performed and documented, the dates on which they were performed, and that any required corrective action has been undertaken.
FDA Quality Record Regulation

Information & Training.

Medical Device:

      • Validation. Classification. Regulation. Requirements. Current best practices.
      • FDA cGMP’s. EU MDR’s / MDD’s.
      • FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
      • FDA Medical Device Classification. The FDA approach to Medical Device Classification.
      • EU Medical Device Regulation and Classification (per MDD’s).
      • New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
      • Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
      • Quality System requirements to maintain compliant Validations.
      • Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
      • 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. …
      • Information & Training presentation >>>

FDA QSR Quality Record Regulation