The increasing popularity of 3D printing is changing the future of health care far more dramatically than we would have ever imagined. Although we have blogged about 3D printing, and the Reed Smith white paper, “3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles” addressed regulatory issues for medical devices and pharmaceuticals (among myriad topics), the regulatory issues warrant continuing attention.
Currently the FDA has approved one 3D printed drug and cleared no fewer than 85 medical devices through the 510(k) process that are made by device manufacturers using 3D printing additive manufacturing processes.
Under the existing FDA regulatory framework, a “manufacturer” is defined broadly to include “any person who designs, manufactures, fabricates, assembles, or processes a finished device.” Although Compassionate Use and Emergency Use pathways remain possibilities in rare circumstances when a hospital or surgeon concludes that on-site printing of a custom implantable medical device is necessary for a particular patient, how the FDA will address non-traditional device “manufacturers” remains an open question. It is hard to imagine hospital 3D printing labs moving beyond using 3D printing for surgical planning purposes, to the printing of custom implantable devices, until the FDA provides further regulatory guidance. Given that they have been looking at these issues, including through a Public Workshop held in October 2014, there is hope that guidance will come soon.
Other open regulatory questions include:
- Will the FDA regulate the 3D printer, or just the end product?
- Will the FDA view shared design files as the unauthorized promotion of the device if the device’s benefits and risks are not disclosed?
- To what extent might FDA exercise its enforcement discretion for 3D products?
These issues, as well as other concerns currently facing this industry, are covered in “3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles.”