FDA has a Discussion paper regarding 3D printing of medical devices at the point of care (PoC) and invites interested parties to provide feedback. Comments from the public will inform policies the agency may issue in the future regarding 3D printing of medical devices in hospitals, doctor’s offices and other healthcare settings.
The potential of 3D printing to revolutionize healthcare is well documented.
For example, the use of 3D-printed patient-specific anatomical models has grown enormously in recent years. This week, Formlabs announced it had signed a deal with Vizient, the largest member-driven healthcare group purchasing organization (GPO) in the United States, becoming the first 3D printing company to be listed in a major GPO catalog. Formlabs’ 3D printers, materials and solutions will be used to convert CT/MRI imaging into patient-specific anatomical models for surgical planning, implant sizing and patient consent.
In the early days of the pandemic, as healthcare providers struggled with shortages of personal protective equipment and even single-use devices, 3D printing provided an agile solution that traditional manufacturing could not.
But, as the FDA points out in its discussion paper, the technology also presents some unique challenges that need to be addressed, especially when used at the point of care. The agency identifies four main areas:
- Ensuring that 3D printed devices are safe and effective, a core task of the FDA;
- applying appropriate controls during the design and manufacture of the product to ensure that product specifications are met;
- Clarifying the entity in charge, around which uncertainty may exist, as it involves device design, testing, FDA pre-market filings, manufacturing, quality control, complaint handling, adverse event reporting and corrective action;
- PoC training and capabilities, complicated by the fact that there are many different types of 3D printing technologies available.
The paper discusses each of these challenges, including through three detailed scenarios, and outlines possible approaches to regulatory oversight. You can help shape the parameters and scope of that supervision by using the 18 page discussion paper and submit comments by February 7, 2022.