Happy New Year! Dr. D hopes all of the readers had a fabulous celebration with your families and a continued prosperous 2016. For this first Devine Guidance of FY 2016, the doctor would like to discuss the virtues associated with having a Device Master Record (DMR) and the consequences for device establishments and Chief Jailable Officers (CJOs) that fail to recognize the need to have a robust DMR. Device establishments and CJOs that fail to recognize the importance of compliance in 2016, this year will not be an annus mirabilis (look-it-up). In fact, it will be quite the opposite, a year of pain and punishment spent in the FDA’s own version of regulatory Hades, with the only sin required for entry being a warning letter. Enjoy!
Warning Letter – November 19, 2015
Considering the DMR is the recipe for manufacturing finished medical devices that are safe and effective in their intended use, how does an establishment or their supplier(s) manufacture a finished medical device without a DMR? Unfortunately, the winner of the warning letter discussed in this week’s guidance failed to have one. In fact, this offending establishment angered the FDA to the point that the agency requested that this establishment cease activities such as commercial distribution immediately. Folks, the doctor seldom, if ever, sees this type of comment placed into a warning letter unless things are really screwed up at the offending establishment.
Warning Letter Excerpt
Observation One: “Failure to maintain device master records as required by 21 CFR 820.181. For example, your firm has not created device master records for the [Medical Device].”
Additional Agency Comment in Warning Letter
“Our office requests that [company] immediately cease activities that result in the misbranding or adulteration of the [Medical Device] and [Medical Device], such as the commercial distribution of the devices for the uses discussed above.”
Subpart M – Records
§820.181 – Device Master Record
“Each manufacturer shall maintain device master records (DMR’s). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with §820.40. The DMR for each type of device shall include, or refer to the location of, the following information:
- Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;
- Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;
- Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;
- Packaging and labeling specifications, including methods and processes used; and
- Installation, maintenance, and servicing procedures and methods.”
Compliance for Dummies
As Dr. D has frequently stated, “this is not rocket science.” It’s broken record time, so repeat after Dr. D; “The DMR is nothing more than the recipe for the manufacture of medical devices.” Guess what? The DMR is not an optional requirement. No DMR equates to no finished medical device, unless an establishment enjoys manufacturing adulterated product. It might be safer for the CJO to poke a sleeping bear in the eye with a sharp stick (please do not try poking the sleeping bear unless you have friends accompanying you that cannot run very fast or at least faster than you). When it comes to constructing a DMR, use the roadmap mentality. It is perfectly acceptable for the DMR to be nothing more than a compiled list of pointers directing to where the appropriate documentation is retained (don’t forget document numbers and titles).
When creating the DMR, the following documents should always be considered for inclusion, as applicable:
- Device Specifications (including all applicable drawings, composition and formulation)
- Component Specifications
- Software Specifications
- Production Process Specifications (including equipment specifications, production methods, production procedures, and production environment specifications, e.g., ISO 14644-1, Class 7)
- Quality Assurance Procedures (including acceptance criteria, and measuring and monitoring equipment to be used)
- Packaging and Labeling Specifications (including all methods and processes employed)
- Installation Procedures and Methods
- Maintenance Procedures and Methods
- Servicing Procedures and Methods
For the CJOs out there who just might struggle with reading comprehension, do not worry. The FDA has actually placed into §820.181 the documents they expect to see connected to the DMR. You can read it over and over again until the requirement sinks into that thick medulla oblongata (look-it-up). Go figure, the FDA defines what they actually want in the DMR in section 820.181. People, it just does not get any easier than this, so no excuses should ever be made for not having a DMR.
For this week’s guidance, the doctor will leave the readers with three takeaways. One: The MDR is nothing more than the recipe needed to manufacture finished medical devices that are safe and effective in their intended use. Two: Having a MDR is not optional. Three: FDA actually spells out in §820.181 what they expect manufacturers to actually place/reference in the DMR. 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.
- Code of Federal Regulation. (April 2015). 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.
- 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. (November 19, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Accessed January 3, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm473657.htm
Indeed, I have always been amazed myself how many of our actual or potential subcontractors are or were not familiar with the notion of a DMR. This holds true for both USA and non-USA based contract manufacturers. Best case, they have a DMR-like record without calling it a DMR. But many issues are unfamiliar to them, e.g., how to address DMR ownership, location, accessibility for regulatory auditors and inspectors, version control and change control, and ensuring the Device History Records demonstrate compliance with the DMR. It is also regrettable that ISO 13485:2003 does not use the term “DMR”, although it refers to such record (ISO/FDIS 13485:2015 now has a section defining a “Medical Device File”). Yet, the requirement to establish a DMR has been around for decades and FDA has provided ample guidance regarding DMR contents. To be continued …
Ary, excellent post. It is my experience, as of late, the FDA has really turned up the heat in an attempt to push device establishments to comply with this salient requirement. I am beginning to see an increase in Form 483 observations citing a failure to comply with 820.181 requirements. Thanks for Reading, Dr. D