Medical device companies have for many years used 3D printing to create innovative products such as custom patient-matched devices and individualized anatomical models for surgical planning. Typically, these activities have occurred within traditional manufacturing facilities. Over the past two years, however, supply chain disruption caused by the COVID-19 pandemic has created medical device shortages that have amplified the use of 3D printing technologies at the point of care. Indeed, healthcare providers have collaborated with 3D printing companies to produce face shields, face mask holders, nasopharyngeal swabs, and ventilator parts within healthcare facilities. As 3D printing technologies improve and healthcare facilities innovate in the face of economic opportunities and pandemic-related challenges, the industry can expect increasing use of 3D printers within the healthcare setting. In turn, FDA is taking notice and has recently issued a paper to facilitate discussion about potential approaches to regulating 3D printed devices at the point of care.
In its discussion paper, FDA highlights the primary regulatory challenges presented by 3D printing at the point of care:
- Providing a “reasonable assurance” that devices that are 3D printed at the point of care are safe and effective.
- Ensuring appropriate design and manufacturing control of devices that are 3D printed at the point of care.
- Clarifying the entity responsible for complying with FDA regulations related to device design, testing, market clearance, manufacturing, quality control, complaint handling, adverse event reporting, and corrective actions.
- Ensuring appropriate capabilities and training of the point-of-care facility to carry out complex processes to produce the final device, such as patient-matching or post-processing activities.
In the context of these challenges, the discussion paper lays out a potential approach for regulating 3D printed devices at the point of care. This approach embodies several long-standing concepts that FDA already employs. For instance, a risk-based approach in which the extent of FDA’s oversight corresponds with the risks associated with both the 3D printing process at the point of care and the final device. The approach seek to further the goals of ensuring that a device meets its design specifications regardless of the location of manufacture and mitigating production risk at the point of care by ensuring appropriate capabilities, oversight, training, and experience and confirming that healthcare facilities that traditionally do not manufacture devices understand their regulatory obligations for a device’s total product life cycle. Employing a least-burdensome approach to provide reasonable assurance of safe and effective devices by leveraging existing standards and processes remains a focal point as well.
The paper contemplates three illustrative scenarios to elicit feedback from stakeholders on the potential regulatory implications of 3D printed devices at the point of care. In the first scenario, a healthcare provider uses a 3D printing medical device production system (MDPS) — a collection of raw materials, digital files, and production and post-processing equipment — to produce specific types of medical devices at the point of care, such as patient-matched anatomic skeletal models for surgical planning or patient-specific dental abutment collars and posts. The manufacturer of the MDPS may receive 510(k) clearance for the 3D printing MDPS, which the healthcare provider uses in accordance with its labeling. Under this scenario, the manufacturer of the MDPS generally would retain responsibility for FDA compliance. However, important questions remain, including the challenges a manufacturer of an MDPS may face in being responsible under FDA requirements for devices that are 3D printed at the point of care, including the effect of post-processing by the healthcare facility; aspects of FDA’s Quality System Regulation that may not be covered by the MDPS manufacturer’s verification and validation; and, how the use of an MDPS at the point of care fits into FDA’s adverse-event reporting system for user facilities and manufacturers.
The second scenario contemplates a traditional manufacturer using 3D printing technology colocated at or near the healthcare facility. For example, a traditional manufacturer receives 510(k) clearance for a spinal fusion cage, which the manufacturer then prints at the point of care using its own equipment and existing quality system. In this scenario, discussion questions include whether patient-specific design changes based on clinical feedback that is immediately implemented during manufacture at the point of care may implicate new 510(k) submission requirement,; and what particular risks should manufacturers and healthcare facilities consider when manufacturing devices outside of the traditional manufacturing setting.
The final scenario envisions that the healthcare facility assumes all traditional manufacturer regulatory responsibilities. Instead of using a previously cleared MDPS or relying on a colocated traditional manufacturer, a healthcare facility may choose to manufacture patient-matched devices itself — such as cranioplasty plates or anatomic surgical models — and to comply with all associated FDA regulatory requirements. This scenario raises questions about the regulatory challenges that a healthcare facility would face, including whether there are parts of FDA’s regulatory framework that would be more or less difficult (or impossible) to implement by healthcare providers at the point of care. Similarly, this scenario raises the question whether there are ways in which FDA may exercise oversight in new or different ways that would be least burdensome but would still provide reasonable assurance of safety and effectiveness.
The events of the past two years have created opportunities and challenges for traditional and nontraditional manufacturers bringing 3D printed devices to the point of care. FDA’s discussion paper is the first step toward building consensus among stakeholders about how to implement the least-burdensome approach to assuring safe and effective 3D printed devices. FDA will use the feedback it receives to inform future policy development, including anticipated draft and final guidances.