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Deciphering the FDA Medical Device QSR

May 1st, 2015 by Henry Macartney

Medical Device ManufacturingAs a medical device manufacturer, how do you identify your compliance obligations? Companies that want to fulfill their duties properly generally look to FDA 21 CFR 820, the Quality System Regulation and the 21 CFR 800 series of regulations. Your firm may also find it useful to incorporate this regulation's precepts into the way you bring products to market.

What's the FDA Medical Device QSR About?

In general, FDA 21 CFR 820 addresses concerns related to the design, planning, manufacture, distribution and use of products. These include audit procedures, personnel requirements, product traceability, process validation, and controls for design, documentation, purchasing and labeling. The regulation seems to have been written to be as comprehensive as possible; it's referenced during everything from self inspections to integrity-driven supplier audits.

What Exactly Does the QSR Stipulate?

FDA 21 CFR 820 is a wide-ranging document. In addition to covering the need for quality systems and their general scope, it also grants the agency the right to undertake certain actions. For instance, a foreign manufacturer who refuses to let an FDA inspector vet their facility may subsequently have their product deemed noncompliant by the FDA. 

Other sections are a more difficult to interpret: Subpart L notes that device manufacturers should maintain instructions for the installation and inspection of their products. While these need to be made available to the user, their format isn't stipulated in the regulations. An organization that wants to distribute digital copies of instructions along with its devices might run into trouble if the FDA deems such efforts insufficient. Naturally, many firms find it wise to seek advisement and QSR clarification prior to implementing marketing strategies. 

Are There Exceptions?

Technically, you have some leeway in how you adhere to the rules. Because the medical device QSR includes quality audit and process validation stages, it also includes the way in which the company should deal with nonconforming products. If your quality controls fail or mistakes occur despite your best efforts, you should have a procedure in place for controlling the defective item or items. Similarly, you need to have review procedures that you can follow to quantify what went wrong. If such root cause analysis concepts sound familiar, you may have encountered them before as part of Corrective and Preventive Action, or CAPA, systems

While such allowances don't exempt your organization from following the rules, your careful adherence may make it easier to comply. Implementing a CAPA system, for instance, will help you get problems under control as they occur and potentially stop them from recurring. 

How Does My Organization Demonstrate Its Compliance Efforts?

Like most regulatory agencies around the world, the FDA isn't just going to accept your word that you've enacted proper quality system controls and features. You'll have to prove that you're following the spirit of the law as well as the letter, and process documentation will serve as your primary form of evidence.

Fortunately, the QSR also includes a number of clauses detailing how firms should annotate quality endeavors and their results. Building an effective documentation framework will also help you defend your devices against regulatory scrutiny. Learn more about keeping your products marketable in the face of FDA action and rulemaking by contacting GxP-CC consultants soon.

For more information, contact us today.


Posted in FDA 21 CFR 820, FDA & European Regulations, FDA Medical Device QSR, GxP CC, Quality System Regulation

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Henry Macartney

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