Let the doctor begin by stating that FDA believes that the DMR is such an important record, it has its own section under 21 CFR, Part 820 – Subpart M (Records). In fact, Dr. D struggles to understand how a device manufacturer can actually manufacture a device without an accurate DMR. Yes, Dr. D clearly understands that with technology and creativity anything is possible. However, the agency is unwilling to ponder the possibilities so investigators are issuing Form 483 Observations for failing to comply with §820.181 (Device Master Record). In some cases, the failure to comply with §820.181 is finding its way into warning letters, a nice attention grabbing tool employed by FDA. It’s the agency’s equivalent of: “CAN YOU HEAR ME NOW?” Folks, you have to remember, compliance to the FDA’s Quality System Regulation (QSR) is not rocket science. In fact, compliance is rather “prosaic” (look-it-up) but a necessary evil if you want to enter medical devices into commerce in the United States. Enjoy!
(a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;(b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;(c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;(d) Packaging and labeling specifications, including methods and processes used; and(e) Installation, maintenance, and servicing procedures and methods.
- 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.
- Code of Federal Regulation. (2012, 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 June 15, 2013, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/