The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:
- The FDA issued an updated FDA COVID-19 Response At-A-Glance Summary that provides a quick look at facts, figures, and highlights of the agency's response efforts.
- The FDA continues to take creative and flexible approaches to address access to critical medical products in response to COVID-19. In partnership with academic researchers, non-traditional manufacturers, communities of makers, and individuals who are banding together to support and fill local and national needs, the FDA is actively engaged and is developing ways to support these groups seeking to help their communities. Our goal is to help expand the availability of relevant products in ways that are consistent with the FDA’s public-health mission.
For example, the FDA is working in partnership with the National Institutes of Health (NIH), the Veterans Administration (VA), and America Makes to support non-traditional manufacturing approaches (e.g., 3D printing), to address device shortages including personal protective equipment (PPE). Through this partnership, 3D-printable designs for COVID response are assessed by the VA, and the NIH posts them on its 3D Print Exchange. The FDA has, among other things, provided information on labeling and testing for face shields and face masks. Today, the FDA web update documents how this partnership has contributed to the number of medical devices — including PPE — and parts available to support the COVID-19 response since its launch 10 weeks ago. For example, 31 community-submitted designs passed the testing performed by VA clinics and were given clinically reviewed status. In addition, this effort has so far matched more than 272,000 3D-printed face shields and more than 230,000 3D-printed face masks with health care providers and others in need. The FDA has issued a temporary policy for face masks and respirators during the COVID-19 public-health emergency.
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