Understanding 21 CFR 820
Like pharmaceuticals, medical devices are regulated medical products. Unlike pharmaceuticals, which are regulated by 21 CFR 210/211, medical devices are regulated by 21 CFR 820. CTI’s Medical Device Consulting Services can provide expertise in both of these regulations can help a medical device firm achieve compliance levels that will impress auditors during your next medical-device centric inspection.
The two regulations read somewhat differently. 820 is also known as “The Quality System Regulation, ‘QSR” for short” meaning that the cornerstone of compliance, from a medical device perspective is a well-functioning quality management system. The pharmaceutical regulation is entitled, “Current Good Manufacturing Practice for Finished Pharmaceuticals,” which implies that the cornerstone of compliance, from a pharmaceutical perspective, is following the GMP rules.
Does this mean that medical device manufacturers get a pass on following GMP rules? No. The major difference between these two regulations is that the medical device regulation is less prescriptive than the pharmaceutical regulation. This is because pharmaceuticals, as a class of products, have more similarities with one another than do medical devices. For example, 211 Subpart E, “Control of Components and Drug Product Containers and Closures,” is applicable for every pharmaceutical drug, whether it’s a topical OTC product, or a sterile injectable prescription-only drug. Medical devices, on the other hand, may, due to the design of the device, be exempt from such prescriptive rules. Examples of such devices might include orthotics, software-as-a-medical-device, and glucose meters.
So how does the QSR enforce GMPs for the devices where containers and closures are critical to the safety of the device; devices such as hypodermic needles, coronary stents, and contact lenses? 820, the QSR, does it through the power of Design Control.
Design Control is a process to identify the Design Inputs, and the Design Outputs, with Design Review milestones to mark the progress as the design of the medical device is continually modified until reaching its final, validated design. The specific risks derived from design of the medical device drives the manufacturing (i.e. GMP) requirements. An orthotic device, for example, will carry different risks from a coronary stent, sterility being a factor that is critical-to-quality for the stent, but of little significance for orthotics. The Design History File (DHF), when reviewed by the FDA auditor, will reveal whether the device risks were considered during the design phase, and whether requirements for training, production, packaging, etc., were established to mitigate those risks.
The FDA need not develop a list of required GMPs for medical device manufacturers because the Design Control process, when followed, should reveal a list of requirements for the manufacturer to implement. In this way, Design Controls becomes an input for all other requirements of the manufacturer’s quality management system, with a focus on GMP requirements that actually matter for the given medical device.
CTI will leave you with word of caution, with regard to medical device requirements. A requirement that is considered enforceable through 210/211 GMPs for pharmaceutical products is presumed relevant for medical devices unless documented justification for waiving the requirement is available for auditor review during an FDA inspection. This is the main reason that medical device manufacturers should understand pharma GMPs even if not specifically followed. These two regulations support one another, and CTI can show you how to unleash the power of 820 (as implied by 210/211) at your company.
Compliance Team has expertise in both medical devices and pharmaceutical products. This breadth of expertise means that CTI can help guide you on a successful medical device compliance journey. Call us today if you need help with implementing a successful medical device quality management system!
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