Which masks are medical devices regulated by the FDA?

Face masks marketed to the general public for general non-medical purposes, such as use in construction and other industrial applications, are not medical devices. Face masks, when they are intended for a medical purpose such as source control (including uses related to COVID-19) and surgical masks are medical devices.

This entry was posted in . Bookmark the permalink.

Leave a Reply

Your email address will not be published. Required fields are marked *