Devices

2 Medical Device Covid Transition Plans

FDA has issued two draft medical device plans for the transition to normal operations from the policies adopted and operations implemented during the Covid-19 public health emergency. “FDA recognizes that it will take time for device manufacturers, healthcare facilities, healthcare providers, patients, consumers, and FDA to adjust from policies adopted and operations implemented during the declared Covid-19 public health emergency,” FDA says.

The first draft guidance, Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency, includes recommendations for submitting a marketing submission, as applicable, and taking other actions with respect to the devices issued EUAs.

A companion draft guidance, Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2018 (Covid-19) Public Health Emergency, describes agency recommendations for transitioning devices that fall within enforcement policies issued during the public health emergency.

FDA says it believes the guidances “will help prepare manufacturers and other stakeholders for the transition to normal operations and foster compliance with applicable requirements under the Federal Food, Drug, and Cosmetic Act and implementing regulations when the relevant EUAs and Covid-19-related enforcement policies cease to be in effect.”

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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