Many individuals new to the medical device industry in the United States may be confused when they hear the acronym QSR. The Food and Drug Administration (FDA) Quality System Regulation (QSR) is based on the Federal Food, Drug and Cosmetic Act, otherwise known as The Act in our industry. The Act is contained in the United States Code (i.e., federal laws), the laws passed by the United States Congress. The QSR can be found in the Code of Federal Regulations (CFR) which is periodically updated and published by Congress. The actual location for the QSR is The Code of Federal Regulations, Title 21 – Food and Drugs, Part 820. In our industry this is commonly abbreviated by 21 CFR Part 820.
QSR is often called current good manufacturing practices and is the basis used by FDA to perform a facility inspection following the Quality System Inspection Technique (QSIT). As the name implies, QSR is the regulation for medical devices. Quoting from the regulation, “this part establishes basic requirements applicable to manufacturers ….” Manufacturers of class II and class III (and certain class I) medical devices sold in the United States are required to comply with this regulation. The regulation states it is to be applied to any finished device “manufactured, imported or offered for import ….” And most importantly the regulation has requirements “intended to ensure that finished devices will be safe and effective ….” What this means is if the medical device is to be available for sale in the United States, the manufacturer must meet the requirements in the regulation.
QSR is not a quality management system for medical devices. The well-known standard in the medical device industry for a quality management system is ISO 13485:2003 Medical devices – quality management systems – requirements for regulatory purposes. The QSR differs from ISO 13485 in many facets, including procedures, records and required investigations. When one reads through the QSR and makes a comparison with ISO 13485, you will notice a significant wording difference. The QSR states ‘the manufacturer shall establish and maintain …” versus the wording of “the organization shall …” found in ISO 13485. The QSR is a regulation and ISO 13485 is a standard.
Failure to meet the regulation is a violation and may result in a warning letter from FDA. A failure to respond to the warning letter in the mandatory fifteen (15) business days after the receipt of the warning letter will result in further consequences for the firm. A hold on the review of regulatory submissions, the refusal to allow the product into the United States, seizure, injunction, and monetary fines are some of the avenues utilized by FDA to resolve a violation. Between January 6, 2012, and April 19, 2012, FDA has issued 160 warning letters with 37 of the warning letters issued to medical device firms for violations of the QSR.
The bottom line – FDA expects compliance with the regulation.