The FDA continues to take creative and flexible approaches to address access to critical medical products in response to COVID-19. Researchers at academic institutions, non-traditional manufacturers, communities of makers, and individuals are banding together to support and fill local and national needs. The FDA is actively engaged across this spectrum and developing ways to assist and support people who are looking to help their communities in these ways. Our goal is to help expand the availability of certain products in ways that are consistent with FDA’s public-health mission.
For example, the FDA is working in partnership with the NIH, VA, and America Makes to support non-traditional manufacturing approaches, such as 3D printing, to address devices shortages including personal protective equipment (PPE). Through this partnership, 3D-printable designs for COVID response are given a clinical assessment by the VA and the NIH posts them on the 3D Print Exchange. FDA has, among other things, provided information on labeling and testing for face shields and face masks.
This page provides an update on how this partnership has contributed to the number of medical devices—including PPE—and parts available to support the COVID-19 response since it was launched in March 2020. For example, 31 community-submitted designs passed the testing performed by VA clinics and were given clinically reviewed status in the first three months. In addition, this effort has so far matched more than 500,000 3D-printed face shields and more than 348,000 3D-printed face masks with health care providers and others in need. FDA has issued a temporary policy for face masks and respirators during the COVID-19 public-health emergency.