Emergency Use Authorizations (EUAs) for surgical face mask manufacturers – 90-day comment period closes
In December of 2021, FDA issued its proposed plan for terminating COVID-19 EUAs for surgical masks as well as other medical devices. Upon issuance of the draft guidance, registrants were given 90 days to comment on FDA’s proposed transition plan.
Summary of comments
As anticipated, the comment period closed on 3/23 and a total of 22 comments were published to the docket (FDA-2021-D-1149). Laurie Clarke, TSG’s VP and Principal of Medical Device Regulatory, will provide a summary of the comments in the coming weeks.
Although it is not yet clear when FDA will formally announce next steps for the guidance document, it appears the Agency is looking to address medical devices operating under EUA’s sooner rather than later.
How can TSG help?
To continue manufacturing and marketing your surgical mask after the EUA is revoked, your company must obtain 510(k) clearance. Not sure what this means or where to begin? Need guidance on whether pursing the 510(k) is worth the effort? Schedule a time to chat with Laurie and have your questions answered.
Get in touch: firstname.lastname@example.org