Failure to maintain adequate device master records, as required by 21 CFR 820.181. For example, the device master records for your manual, half-powered, and full-powered wheelchairs are incomplete because they do not include or refer to the location of production procedures. Your firm has not established procedures for the assembly of manual wheelchair (Model #SS-1) with folding frame; assembly of half-powered wheelchair (Model #HPS-2); assembly of full-powered wheelchair (Model #PS-2); and welding of the frame, and armrest assembly.

Device Master Record

There are two ways of skinning the proverbial cat when it comes to DMR creation. One – you can actual assemble all of the appropriate documentation and place it into a DMR (electronically or paper copy). Two – a simple pointer document can be created that identifies all of the DMR documents and their locations (once again, electronically or paper). See, this really isn’t rocket science, so how come device manufacturers are struggling with this requirement?

The next step toward complying with §820.181 is correctly identifying all documents needing to be captured in the DMR. Now if you can read, and the doctor is going to climb out on the limb and assume that if you made it this far into this week’s guidance you probably can, the documents are actually listed in §820.181. How dare the agency trick everyone and actually provide the information they want device manufacturer’s to document and employ. For those of you that are too lazy to read through boring stuff, like regulations, Dr. D will list out the documents that are typically placed into the DMR. 

• 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; and
• Servicing Procedures and Methods. 

Finally, do not forget to maintain the DMR. For example, if the packaging modality changes from a Poly-Tyvek pouch to a breather bag, you need to ensure this information actually makes it into the DMR. The same holds true for component changes, process changes, and anything else that is used to manufacture the finished medical device, minus the operators of course.

Takeaways

For this week’s guidance, Dr. D will leave the readers with two takeaways. One – you must have a Device Master Record, so just go ahead and create one. Two – once the DMR has been assembled, do not forget to update it. For those of you blessed with electronic document control and data management systems, the task of keeping a DMR current should be a relatively benign task.  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. (2012, 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 June 15, 2013, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/