Medical device companies have used 3D printing for many years to create innovative products such as personalized patient-specific devices and individualized anatomical models for surgical planning. Typically, these activities have taken place in 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 point-of-care 3D printing technologies. Indeed, healthcare providers have collaborated with 3D printing companies to produce face shields, face mask holders, nasopharyngeal swabs, and ventilator parts in healthcare settings. As 3D printing technologies improve and healthcare facilities innovate in the face of economic opportunities and pandemic-related challenges, the industry can expect increased use of 3D printers in healthcare. health. In turn, the FDA takes notice and recently published an article to facilitate discussion of potential approaches to regulating point-of-care 3D printed devices.
In its working paper, the FDA highlights the key regulatory challenges presented by point-of-care 3D printing:
- Provide “reasonable assurance” that 3D printed devices at the point of care are safe and effective.
- Ensure proper design and manufacturing control of 3D printed devices at the point of service.
- Clarify the entity responsible for complying with FDA regulations relating to device design, testing, marketing authorization, manufacturing, quality control, complaint handling, reporting adverse events and corrective actions.
- Ensure the appropriate capabilities and training of the point-of-care facility to perform complex processes to produce the final device, such as patient matching or post-processing activities.
In the context of these challenges, the discussion paper presents a potential approach to regulating 3D printed devices at the point of care. This approach embodies several longstanding concepts that the FDA is already using. For example, a risk-based approach in which the scope of FDA oversight matches the risks associated with both the point-of-care 3D printing process and the end device. The approach aims to promote the goals of ensuring that a device meets its design specifications regardless of where it is manufactured and to mitigate production risks at the point of service by ensuring capabilities, oversight, training and appropriate experience and confirming that healthcare facilities that traditionally do not manufacture devices understand their regulatory obligations for the full product lifecycle of a device. Using a least burdensome approach to provide reasonable assurance of safe and effective devices by leveraging existing standards and processes also remains a focus.
The paper considers three illustrative scenarios for obtaining stakeholder feedback on the potential regulatory implications of point-of-care 3D printed devices. 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 point-of-care medical devices, such as patient-tailored anatomical skeletal models for surgical planning or patient-specific dental abutment collars and posts. The manufacturer of the MDPS may receive a 510(k) authorization for the 3D printing MDPS, which the healthcare provider uses in accordance with its labeling. In this scenario, the MDPS manufacturer would generally retain responsibility for FDA compliance. However, important questions remain, including the challenges an MDPS manufacturer may face in being liable under FDA requirements for point-of-care 3D printed devices, including the effect of post-processing by the health facility; aspects of FDA’s quality system regulations that may not be covered by MDPS manufacturer verification and validation; and how the use of a point-of-care MDPS fits into the FDA’s adverse event reporting system for user facilities and manufacturers.
The second scenario envisions a traditional manufacturer using 3D printing technology co-located in or near the healthcare facility. For example, a traditional manufacturer receives a 510(k) clearance for a spinal fusion cage, which the manufacturer then prints at the point of service using their own equipment and existing quality system. In this scenario, questions for discussion include whether patient-specific design changes based on clinical feedback that are immediately implemented during point-of-care manufacturing may trigger a new 510(k) submission requirement; and what special risks should manufacturers and healthcare facilities consider when manufacturing devices outside of the traditional manufacturing framework.
The final scenario envisions the healthcare facility assuming all the traditional regulatory responsibilities of the manufacturer. Instead of using a pre-approved MDPS or relying on a traditional co-located manufacturer, a healthcare facility can choose to manufacture patient-specific devices themselves – such as cranioplasty plates or anatomical surgical models – and to comply with all associated FDA regulatory requirements. This scenario raises questions about the regulatory challenges a healthcare facility would face, including whether there are parts of the FDA regulatory framework that would be more or less difficult (or impossible) for healthcare providers to implement. health at the point of care. Likewise, this scenario raises the question of whether there are ways in which the FDA can exercise oversight in new or different ways that would be less burdensome but still provide reasonable assurance of safety and effectiveness.
The events of the past two years have created opportunities and challenges for traditional and non-traditional manufacturers bringing 3D printed devices to the point of care. The FDA’s discussion paper is the first step toward building consensus among stakeholders on how to implement the least burdensome approach to ensuring safe and effective 3D printed devices. FDA will use the feedback it receives to inform future policy development, including planned interim and final guidance.