by John H. Fuson and Hilary Johnson
In December, the U.S. Food and Drug Administration (FDA) issued a discussion paper soliciting feedback on its contemplated approach to regulating 3D printing of medical devices at the point of care (POC). U.S. Food & Drug Administration, Discussion Paper: 3D Printing Medical Devices at the Point of Care, (Dec. 10, 2021) (www.fda.gov/medical-devices/3d-printingmedical-devices/3d-printing-medical-devices-point-care-discussion-paper). The FDA’s paper outlines potential benefits and challenges of this capability. It underscores that quick and adaptable production of devices, production of personalized devices, and innovation must be balanced with a regulatory framework that ensures adequate safety and efficacy. The FDA appears appropriately attuned to the issues that the existing regulatory framework presents in this space and seeks to incorporate more flexibility. Nevertheless, entities need to carefully consider the legal implications of their printing activities. In particular, the details of how, where, and by whom devices are 3D-printed at the POC may significantly impact both regulatory compliance obligations as well as the risk of product liability litigation.
POC Printing Benefits and Challenges: Disrupting Traditional Manufacturing Models Among other advantages, 3D printing allows the creation of personalized medical devices like patient-matched models for surgical planning, implants, and surgical instruments. 3D printing devices at the point of care takes this capability a step further by reducing or eliminating the gap between healthcare provider and device manufacturer. Additional advantages include the potential to reduce reliance on global supply chains. During the COVID-19 pandemic, for example, facilities used 3D printing to make devices that they could not obtain due to supply chain disruption, such as ventilator parts and face shields, using locally available materials.
3D printing at a POC can occur in a variety of settings. Three potential scenarios that the FDA contemplates are: (1) a healthcare facility using an approved or cleared 3D printing system, manufactured by a traditional manufacturer, to print devices in accordance with the intended use; (2) a traditional manufacturer located at or near a healthcare facility’s POC 3D printing devices for the healthcare facility; or (3) a healthcare facility assuming the role of a traditional manufacturer by, for example, 3D printing according to its own specifications, designs, etc. While the first two scenarios closely track traditional manufacturing arrangements, the third scenario raises particularly thorny regulatory and other legal issues because of the way such a printing arrangement muddies the distinction between traditional manufacturers and healthcare providers.
Clinical healthcare providers, such as hospitals, doctors’ offices, or dentists, which are focused on patient care, do not typically engage in manufacturing or design of medical devices. But a healthcare facility that 3D prints medical devices according to its own specifications and designs, or that undertakes post-processing activities such as sterilization or heat treatment, may be performing activities legally defined as “manufacturing” or “design.” As a result, these facilities may face both regulatory compliance obligations and the prospect of product liability litigation—realities that can be costly and put a damper on innovation. Entities should consider these potential legal issues when establishing their POC printing arrangements.
Regulatory Compliance Challenges Entities engaging in activities considered to be “manufacturing” under the Federal Food, Drug, and Cosmetics Act (FDCA) are subject to the FDA’s manufacturing regulations. These federal regulations include requirements such as premarket clearance or approval for the device/system, quality system regulations, and post-market surveillance. See, e.g., 21 CFR pt. 820; 21 CFR pt. 803; 21 CFR § 860.3. Where a healthcare facility is performing manufacturing activities in the context of 3D POC printing, however, applying existing regulations designed for traditional manufacturers may not be desirable or necessary. For example, existing regulations don’t account for quality controls that sophisticated healthcare facilities may already have in place that could be leveraged for use in the manufacturing activities they are engaging in. Similarly, healthcare facilities that outsource the 3-D printing to others but who engage in certain post-processing may already have procedures in place that govern these activities.
In grappling with these challenges, the FDA appears focused on developing broad regulatory principles, such as a risk-based framework and end-product consistency. Concepts the FDA is considering include: using a risk-based approach in which the extent of oversight corresponds with degree of risk; using existing capabilities and controls of a healthcare facility to manage 3D printing risks; and ensuring entities understand which requirements of the FDCA apply to them.
With final FDA guidance still some time away, however, it is not clear what the burden of regulatory compliance for any given type of 3D printing arrangement will ultimately be. In the short-term, healthcare facilities engaged in manufacturing activities remain subject to the same stringent regulatory requirements as traditional manufacturers. And while an updated regulatory approach may bring a degree of flexibility, it is likely that healthcare entities performing manufacturing activities will remain subject to FDA regulatory oversight. At a minimum, healthcare facilities not traditionally in the manufacturing business face a steep learning curve as they work to comply with current and future regulations.
Product Liability Pitfalls Healthcare facilities engaged in 3D POC printing should also consider the product liability litigation exposure that could result from assuming the role of a traditional manufacturer. Because they are typically focused on the practice of medicine, healthcare facilities are likely accustomed to medical malpractice litigation. But facilities may become targets of medical device product liability litigation if they opt to perform their own 3D printing instead of outsourcing it to a traditional manufacturer. Product liability litigation not only exposes healthcare facilities to an entirely new and very active area of potential liability, but comes with unique challenges that healthcare facilities may not be accustomed to facing. For example, in many jurisdictions, manufacturers are subject to strict liability for their products. This means that facilities engaged in manufacturing or design of devices may be held liable for injuries resulting from defects in their products notwithstanding the reasonableness of their actions. Additionally, unlike medical malpractice, there are typically no statutory caps on damages or pre-suit notification requirements in the product liability context. 3D printing arrangements that merge the roles of manufacturer and healthcare provider may also mean that many traditional product liability defenses, such as learned intermediary, innocent seller, and indemnification, won’t apply.
Looking Forward Healthcare facilities considering 3D POC printing are best positioned to evaluate the type of 3D printing arrangement that meets their needs. They should do so with an understanding of the legal costs and risks associated with certain arrangements—particularly those where the healthcare facility itself is engaging in 3D printing beyond simply using an FDA approved or cleared 3D printer for its intended use. Managing these risks may, in some cases, counsel toward maintaining a more traditional allocation of manufacturing versus healthcare services. Entities in the 3D POC printing space should look for further guidance from the FDA on its evolving regulatory approach and be alert to litigation developments as 3D printing at a POC becomes more prevalent.
John H. Fuson is a partner in Crowell & Moring’s Health Care, Product Risk Management (PRM), and White Collar and Regulatory Enforcement groups in Washington, D.C., focusing on U.S. Food and Drug Administration (FDA) enforcement and counseling matters. Previously, he served as associate chief counsel at the U.S. FDA. He can be reached at jfuson@crowell.com. Hilary Johnson is a Mass Tort, Product, and Consumer Litigation counsel in Crowell & Moring’s Washington, D.C. office. She can be reached at hjohnson@crowell.com.