It seems that more than ever, our dear friends from the agency are focusing on design controls when they decide to drop in for that friendly chat over a cup of coffee and an inspection. From Dr. D’s perspective, the doctor is just not sure how an establishment can successfully design and develop medical devices that are safe and effective in their intended use without following the basic design control rules established within §820.30. Additionally, the establishment of something as simple as the design history file (DHF), the basic receptacle for all design and development activities, really does become the complete design and development history for a device. How an establishment can fail to create one for each product or family of products is beyond Dr. D’s comprehension. The way Dr. D sees it, the creation of the DHF should essentially be a transpicuous (look-it-up) process that is used to establish the baseline for the design and development of a medical device. Failure to establish a DHF and bad things such as Form 483 observations and a prized FDA warning letter will be in an offending establishment’s future. No crystal-ball or clairvoyant powers will be needed to peer into the future to see bad things happening to an offending establishment or the tears pouring out of the eyes of the establishment’s Chief Jailable Officer (CJO). Enjoy!
Warning Letter – February 23, 2017
Approximately three weeks ago, Dr. D visited this same warning letter awarded to an offending establishment. Obviously, 13 Form 483 observations is a lot of cannon fodder for Dr. D; however, it also makes for a superb opportunity for learning experiences. Now granted, 13 was clearly an unlucky number for the CJO tasked with navigating the often treacherous regulatory waters associated with the FDA. However, it is Dr. D’s humble opinion; observations associated with design controls can be prevented with a well-documented approach to design and development. Additionally, failing to establish a DHF is always going to end badly. In fact, the FDA will almost always take a look at the DHF, device master record (DMR), and device history record (DHR) during a visit for that cup of coffee and an inspection. Seriously, three acronyms all CJOs should become quite familiar with are: (a) DHF, (b) DMR, and (c) DHR (four if you count CJO).
Warning Letter Excerpt
Observation Three (3) – “Failure to establish a design history file as required by 21 CFR 820.30(j). For example, your firm has not established a Design History File (DHF) for the Tio-H Digital X-Ray Sensor System.”
21 CFR, Part 820.30(j)
(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.
Compliance for Dummies
There really is not much to understanding what records are retained in the DHF. Simply stated, anything that can be used to support documented evidence of compliance with §820.30 needs to be captured in the DHF. The good news is device establishments can use today’s technology to create an electronic DHF. With software such as Master Control (note: Dr. D is not a paid spokesperson for this product), automating the entire DHF is a relatively easy task. However, if an establishment is inclined to create a DHF the old-fashion way, through the use of paper and killing trees (not popular in tree-hugging states like California), that is acceptable too! Records and documentation that will find its way into the DHF will be:
- Design inputs and outputs (e.g., quality, regulatory, & statutory requirements)
- Design and development plan (e.g., MS Project Gantt Chart)
- List of project team members
- Product, market, and software specifications
- Design review meeting minutes
- Risk management plan and report
- Hazard Analyses
- Clinical Risk Benefit Analyses (CRBAs)
- Component drawings, circuit board layouts
- Design verification and validation protocols and testing results
- External testing (e.g., sterilization validation, package testing, and biocompatibility testing)
- Product labeling (including IFUs and user manuals)
- Any other document or record relevant for supporting the design and development
For this week’s guidance, Dr. D will leave just one takeaway for the readers. The DHF is not optional. It is a salient requirements spelled out in §820.30(j). The best advice Dr. D can offer the readers is that when that initial project meeting is held for that new product design, the DHF should be opened immediately. Managing the information chronologically, considering design and development activities occur in phases, is probably going to be the best way to retain documentation and records. Please keep in mind the use of an electronic DHF versus paper is entirely up to the establishment. In closing, thank you again for joining Dr. D, and I hope you found value (and some humor) in the guidance provided. Until the next installment of DG, cheers from Dr. D., and best wishes for continued professional success.
- Code of Federal Regulation. (April 2016). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
- Code of Federal Regulation. (April 2016). Title 21 Part 803: Medical device reporting. 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.
- Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
- FDA. (February 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. Denttio, Inc. Accessed March 31, 2017. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm543694.htm
Hi Dr. D,
We worked together many years back for Boston Scientific. I have a question for you about Design Controls vs. Business Practices. We recently changed are design control process and removed those functions not applicable to 820.30 into business practices. I’d like to know your thoughts about this and how it may affect our ISO 13485 certification ?
Tim, How are you my friend? Thanks for reading DG and great question by the way. As you know ISO 13485, Clause 7.3 and 21 CFR, Part 820.30 have been fairly well-aligned over the years. For the FY 2016 version of the standard, there have been a few more minor changes such as the Medical Device File, the Design and Development Files, and the separating of DV and D-Val into separate sub-clauses. Marry these changes with the increased importance placed on Risk Management and 2018 and beyond are going to be interesting times in the ISO world. As long as you have a strong matrix that maps your QMS to the ISO 13485:2016 clauses and 21 CFR, Parts 801, 803, 806, & 820; I think you will be fine. Give me a call sometime and we can discuss further. Be Well, Dr. D