A recent Federal Register notice governed only limited pre-approval marketing.
This is to correct our item of a few days ago that wrongly announced the approval of certain new categories of experimental license – obviously a product of wishful thinking.
The Federal Register notice we cited there approved only Section 2.803(c)(2), which permits limited marketing of not-yet-approved devices, including evaluation kits, and requires certain information to customers and labeling.
Approval of the three new categories of “Program,” “Medical Testing,” and “Compliance Testing” licenses is still probably several months away.
We regret the error.