By: Suzan Onel
FDA issued a Press Release on March 28, 2020, reiterating what we all have seen in the news, there is a severe shortage of personal protective equipment (PPE) in health care facilities across the country. In response to the shortages, FDA has issued Emergency Use Authorizations (EUAs) for respirators, ventilators, ventilator tubing connectors, and ventilator accessories; modified importation rules to facilitate import of PPE; initiated outreach to textiles manufacturers to make masks; and developed conservation strategies for surgical masks, gowns, and gloves.
In parallel with these efforts, there has been a resurgence of interest by stakeholders in the promise of 3D printed devices to help meet demand and interruptions to the global supply chain. 3D printing, also known as additive manufacturing, is a process that creates a three-dimensional object by building successive layers of raw material. The objects are produced from a digital 3D file such as a computer-aided design drawing or a Magnetic Resonance Image (MRI). 3D printing enables manufacturers to produce devices with complex internal structures and patient-specific devices that are matched to a patient’s anatomy by using the patient’s own medical imaging. Examples of 3D printed medical devices include external prosthetics, orthopedic and cranial implants, dental restorations, and surgical instruments.
FDA currently regulates 3D printed medical devices in the same manner as traditional medical devices with the same regulatory requirements and premarket submissions expectations. See Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Additive Manufactured Medical Devices (Dec. 2017) (“3D Printing Guidance”). The 3D Printing Guidance outlines FDA’s recommendations for 3D-printed devices, including technical considerations related to process validation and acceptance activities for finished devices, design and manufacturing considerations to fulfill Quality System requirements, and device testing considerations to address information that should be provided in the 3D printed device’s premarket submission.
While FDA states in the 3D Printing Guidance that it expects that only in “rare cases” will 3D printing raise different questions of safety and/or effectiveness, FDA is more cautious in its recently issued FAQs on 3D Printing of Medical Devices, Accessories, Components, and Parts During COVID-19 Pandemic. FDA states in the FAQs that “while it is possible to use 3D printing to make certain PPE, there are technical challenges that have to be overcome to be effective enough. For example, 3D-printed PPE may provide a physical barrier, but 3D-printed PPE are unlikely to provide the same fluid barrier and air filtration protection as FDA-cleared surgical masks and N95 respirators.”
FDA encourages entities interested in 3D printing components, parts or accessories for use with medical devices to work with relevant medical device manufacturers to assure components and parts have the same specifications, dimensions and performance characteristics. FDA also invites companies interested in 3D printing entire medical devices to contact the Agency at COVIDManufacturing@fda.hhs.gov since “some devices are more amenable to 3D printing than others.”
To facilitate sharing of data and coordinate on open-source medical products for the COVID-19 response, FDA recently signed a Memorandum of Understanding (MOU) with the Department of Veterans Affairs (VA) Innovation Ecosystem and the National Institutes of Health (NIH) 3D Print Exchange. These agencies are also working closely with America Makes, a large public-private partnership with members that span all sectors of the 3D printing industries, to provide resources that will connect health care providers and 3D printing organizations.
For more information on the role of these stakeholders and the status of various 3D printable parts and designs for medical products during the COVID-19 pandemic, we provide their links here: Department of Veterans Affairs Innovation Ecosystem connector site, National Institutes of Health 3D Print Exchange COVID Collection, and America Makes COVID-19 Health Care Needs and AM Capabilities Repository.
Our firm is following closely FDA’s policy on 3D-printed devices and its other initiatives to respond to the public health emergency posed by the COVID-19 Pandemic. Please contact us if you have any questions or would like to discuss further.