21 CFR 820.60 Identification. Identification of Medical Device

To be in compliance with this section of identification, sponsor should always establish procedures and protocols to provide a system and instruction for product identification. It is not only apply to finished products, the system should also apply to materials, parts, sub-assemblies and other critical components.

Sponsor should establish part number and device configuration record and traceability record. Purchased materials, parts and components are identified with unique numbers, codes, or names. The identifications should be maintained while the ‘products’ are in the production, finished product, storage and even at consumers locations.

Identification should be performed during production. During all stages of production, manufactured parts and sub-assemblies are identified by the work order. Work orders accompany products as they move from one workstation or production process to the next.

Identification should be performed during finished product. Finished products are identified by a label that is permanently affixed to the product. The identification label includes the name and model of the product; the name, address and phone number of the manufacturer; and the serial or lot number.

Identification of Returned Product: Products returned for servicing are brought to the receiving desk in the servicing department and are tagged with the service job number. New products returned for exchange, refund or for any other reason are labeled HOLD and are placed in a designate a holding (quarantine) area before moving redistribution area or being repaired.

The following is the exact wording from FDA website.

Sec. 820.60 Identification.

Each manufacturer shall establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mixups.

1.     –CFR-Code of Federal Regulation Title 21 part 820 Quality System Regulation, www.fda.gov, page last updated 06/01/2013.

The next I shall blog about traceability of product.

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.