Identification and Traceability – Medical Device GMP

21 CFR 820 Subpart F of the Code of Federal Regulations (CFR) pertains to "Identification and Traceability" and contains regulations that outline the requirements for medical device manufacturers to establish and maintain processes for identifying and tracing their devices throughout the manufacturing and distribution process. The goal of these regulations, enforced by the Food and Drug Administration (FDA), is to ensure that medical devices can be tracked and traced to their source, facilitating product safety and quality control.

Here are key elements and requirements outlined in 21 CFR 820 Subpart F:

  • Unique Device Identification (UDI): Manufacturers must comply with UDI requirements, which include assigning a unique identifier to each medical device, packaging, and label. The UDI must be maintained throughout the device's distribution and use.

  • Device Labeling: Devices must be labeled with information that allows for their identification and traceability. This includes the UDI, lot or batch numbers, and expiration dates where applicable.

  • Device History Record (DHR): Manufacturers must establish and maintain a DHR for each batch or lot of devices they produce. The DHR should contain records of the production process, including dates, quantities, and identification of all components used.

  • Traceability Records: Manufacturers are required to establish procedures for maintaining records that allow for the identification of devices and their components, including records of where each device was shipped.

  • Labeling Records: Records related to the labeling of devices, including the UDI, must be retained for a specified period, typically at least two years after device distribution.

  • Handling and Storage: Manufacturers should have procedures in place for the proper handling and storage of labeled devices to prevent damage or deterioration of labels and identification marks.

  • Identification of Serviceable Devices: Manufacturers must ensure that serviceable medical devices are identified as such, and their maintenance and servicing activities should be recorded and traceable.

  • Nonconforming Products: Procedures should be established for addressing and documenting instances of nonconforming devices, including their identification, segregation, and disposition.

  • Labeling Changes: Manufacturers must have procedures for documenting and evaluating any changes made to device labeling, ensuring the traceability of these changes.

  • Records Retention: Records related to identification and traceability should be retained for a specified period, typically at least one year after the expiration date of the medical device.

These requirements are critical to ensuring that medical devices can be accurately identified and traced throughout their lifecycle, from production to distribution and use. Compliance with these regulations is essential for maintaining product quality and safety, as well as for meeting FDA regulatory requirements.

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