(j) Design history file. Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.FDA Warning Letter – Meridian Medical Systems (03 July 2013)In the case of Meridian Medical Systems, FDA decided that a famous Monopoly move was in order; “Do not pass go and do not collect your $200!” In an effort to further “ingratiate” (look-it-up) their organization with the agency, Meridian provided a vague response to the Form 483 observation. That being said, FDA’s warning letter stated:These violations include, but are not limited to, the following:1. Failure to establish a design history file, as required by 21 CFR 820.30(j). Specifically,Your firm does not have a design history file (DHF) for the Meridian DR 200 single panel X-ray system. The system is comprised of a workstation, flat panel detectors, acquisition software and X-ray hardware. Missing elements of the DHF include:
• A design plan for the project• Established or approved design inputs/outputs for the system• Verification or Validation testing for the system• Design Transfer• Risk Management for the system• Design Reviews.
- Design & Development Plan;
- Market Specification;
- Product Specification;
- Verification Protocols;
- Validation Protocols;
- All Procedures Defining the Design & Development Process;
- Design Reviews;
- Test Reports;
- Bill of Materials;
- Subsequent Design and Process Changes; and
- All remaining Documentation related Device Design and Development.
Until the next installment of DG – cheers from Dr. D. and best wishes for continued professional success.
- Code of Federal Regulation. (2013, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
- FDA – U.S. Food and Drug Administration Website. (2013, June). Warning letters. Retrieved July 27, 2013, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm359625.htm