Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Design History File

By Dr. Christopher Joseph Devine
Dr. Christopher Joseph Devine, President, Devine Guidance International

FDA considers the Design History File documented evidence that a medical device was designed and developed in accordance with §820.30; if documented evidence does not exist, FDA will issue a Form 483 observation or even a warning letter.

 
 
Dr. D has noticed a disturbing trend as of late, device manufacturers failing to establish a Design History File (DHF). Seriously folks, the doctor is having great difficulty in fathoming how the manufacturer of medical devices does not understand the concept of establishing a DHF. Considering the amount of work required in support of compiling a 510(k) or a PMA submission, the doctor’s assumption is that some of the supporting documentation would be extracted from the DHF. In fact, the entire design and development process should be using a DHF as the primary receptacle for the collection of all design and development activities. Can you say documented evidence? You see, FDA considers the DHF documented evidence that a medical device was designed and developed in accordance with §820.30. If documented evidence does not exist, the FDA will issue a Form 483 observation or in the case of Meridian Medical Systems, a warning letter.
Subpart C – – Design Controls
Sec. 820.30
(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.
 
If you haven’t figured out by now, it is Dr. D’s humble opinion, the DHF is an immensely important collection of records. As previously stated, the DHF is the receptacle for all documentation associated with the entire design and development process, including design changes made after design transfer. Besides, FDA will ask to see the DHFs during one of their friendly visits. A well-constructed DHF is always the best friend, although an “inanimate” (look-it-up) one, of the quality and regulatory professionals sitting across from the FDA during establishment inspections. 
Documentation placed into the DHF should include (not an all-inclusive list):
  1. Design & Development Plan;
  2. Market Specification;
  3. Product Specification;
  4. Verification Protocols;
  5. Validation Protocols;
  6. All Procedures Defining the Design & Development Process;
  7. Design Reviews;
  8. Test Reports;
  9. Drawings;
  10. Specifications;
  11. Bill of Materials;
  12. Routers; 
  13. Subsequent Design and Process Changes; and
  14. All remaining Documentation related Device Design and Development.
Organizations that fail to create and/or maintain a DHF risk suffering through the same fate of Meridian Medical Systems, a Form 483 observation and a subsequent warning letter.
Takeaways
For this week’s guidance, the doctor will leave the readers with two takeaways. One – the DHF is a salient requirement of the design control process so best industry practice is to create one at the start of the design and development process. Two – make sure you treat the DHF as the ultimate receptacle for the collection of “documented evidence” for all design and development activities.   Remember, the FDA will ask to see and perform a review of the DHF during one of their friendly establishment inspections. In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided.

Until the next installment of DG – cheers from Dr. D. and best wishes for continued professional success. 

References: 

  1. Code of Federal Regulation. (2013, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
  2. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
  3. 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
 
 
 
 

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Dr. Christopher Joseph Devine, President, Devine Guidance International