Innovation to Respond to COVID-19

FDA acknowledges that lots of stakeholders are interested in creating and producing 3D printed gadgets during the COVID-19 public health emergency. We are likewise conscious that stakeholders typically do not know what gadget designs to choose or how much to print. In light of this and as part of our effort to secure the general public to the degree possible, FDA is helping with information-sharing regarding making use of 3D printing and other advanced manufacturing technologies in the context of individual protective equipment (PPE) and other medical gadget parts. To this end, the FDA entered a Memorandum of Comprehending (MoU) with the Department of Veterans Affairs (VA) Development Environment and the National Institutes of Health (NIH) 3D Print Exchange, to share data, and coordinate on open-source medical products for the COVID-19 response. These agencies are likewise working carefully with America Makes, to provide resources that will connect health care companies and 3D printing organizations.

FDA accelerates the advancement of prevention and treatment options for COVID-19 by offering brand-new guidance with recommendations for innovators and researchers. These guidance documents aim to make the procedure for submitting applications to start research studies for new drugs and biological items more effective and summary recommendations for ways to design clinical trials to evaluate security and efficiency of these medical products for COVID-19.