FDA Quality System Regulation

Information & Training. | Medical Devices.

Medical Device Identification. Medical Device Traceability

There are a number of objectives associated with medical device identification and medical device traceability requirements. If a failure or non-conformance is identified at any stage throughput the entire supply and manufacturing process or within patient use, then the manufacturer needs to be able to identify the potential impact on other devices or other batches, lots, etc.. For example, if a supplier contacts a manufacturer to indicate potential of a formulation mix-up on a chemical formulation supplied into a device/drug combination medical device, then the manufacturer needs to be able to track forward and identify all potentially impacted devices. Equally, if a clinician identifies a fault with a device in use in the market, then the manufacturer needs to be able to track back through manufacturing and back into the supply chain to identify the potential cause and extent of process control failure and again track forward and identify other potentially affected devices.

Clearly the extent of required identification and traceability will be determined by the potential severity of device non-conformance or failure. The manufacturer needs to define, justify and document their approach to identification and traceability.

The FDA requires clear identification procedures to be established to ensure product and raw material mix-ups cannot arise throughout the supply, manufacturing and distribution processes.

Medical Device traceability requirements increase for the higher criticality devices and the device history record needs to identify the necessary control identifiers (e.g. lot, batch, serial numbers, etc..).

Validation. Classification. Regulation. Requirements. Current best practices.
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TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H–MEDICAL DEVICES

PART 820 QUALITY SYSTEM REGULATION

Subpart F–Identification and Traceability

Sec. 820.60 Medical Device Identification.
Each manufacturer shall establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mix-ups.

Sec. 820.65 Medical Device Traceability.
Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user shall establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components. The procedures shall facilitate corrective action. Such identification shall be documented in the DHR.

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. …
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