Devices

3D Printed Swab Town Hall

A 5/15 CDRH virtual town hall discussed a joint FDA, National Institutes of Health (NIH), Veterans Administration (VA) project on 3D printing of nasal swabs during the Covid-19 public health emergency. Participants noted that an FDA Covid-19 policy guidance intends to help accelerate the availability of novel coronavirus tests developed by laboratories and commercial manufacturers for the duration of the public health emergency.

A memorandum of understanding (MOU) among the three federal agencies was discussed at the meeting, as was the role of the NIH 3D print exchange that was started in 2013

VA Health Care System 3D printing network director Beth Ripley said the VA role under the MOU is to consider all of the unique features that go into 3D printed swabs and develop the testing protocol that will demonstrate equivalents to the standard of care. The protocol will be shared publicly under the spirit of the MOU, she said.

Much of the meeting centered on a presentation of some of the considerations that may be valuable to provide consistency in developing and validating 3D printed swabs by CDRH associate director for medical affairs and chief medical office Sara Brenner.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome