Medical Device Supply Chains and FDA Regulatory Oversight
The U.S. Food and Drug Administration (FDA) has regulatory responsibility for all medical devices sold in the United States, a category that includes an estimated 80,000 different items. The “medical device” classification covers a broad range of products, ranging from low-risk bandages and tongue depressors to life-sustaining heart valves and pacemakers, and everything in between.
How then, does the FDA establish regulatory “rules of the road” for such a broad array of products? For starters, all manufacturers must establish “quality systems” to ensure their products consistently meet applicable requirements and specifications. Medical device quality systems are known as “current good manufacturing processes” (CGMP), with specific requirements found in “Title 21” of the Code of Federal Regulations (CFR). A more precise location is Title 21 CFR Parts 800-1299. Not surprisingly, the requirements cover various aspects of design, clinical evaluation, manufacturing, packaging, and labeling of medical devices.
But the regulations also address logistics-related aspects of the medical device supply chain. Subpart L of the regulation is titled, “Handling, Storage, Distribution, and Installation,” and among other things, directs a manufacturer to establish control and distribution procedures, and a process for ensuring expired or “deteriorated” devices are not distributed.
The regulations do not dictate specifically what a quality system should look like, or how it should be implemented. “Because [these regulations] must apply to so many different types of devices,” the FDA guidance states, “it does not prescribe in detail how a manufacturer must produce a specific device.”
Instead, manufacturers are advised to “use good judgment” when developing their quality system. Each manufacturer has the responsibility to establish requirements that will ensure the safety and effectiveness of their devices. Manufacturers are also responsible for establishing methods and procedures to “design, produce, distribute, etc. devices that meet the quality system requirements,” as described by the FDA.
Since device manufacturers often rely on third-party-logistics providers to manage their warehouse and distribution functions, it’s essential for suppliers to understand their role in the compliance process. Great care must also be exercised to ensure a supplier can perform the required responsibilities. For example, a manufacturer of temperature-sensitive devices would want to ensure that a logistics provider’s storage facilities and vehicles had the required temperature-control capabilities. Or that a fulfillment center is able to meet FDA inventory requirements designed to ensure expired products are removed from the distribution process.
Not surprisingly, the FDA takes very seriously its role in medical device regulation. The number of “483 observations,” which are notifications sent to advise manufacturers about a possible violation, increased by almost 15 percent during 2017. The more serious action of “warning letter” issuance declined, which is a positive trend. These FDA corrective actions cover a broad range of possible violations, including problems with logistics-related activities.