Punchline: The FDA EUA transition plans require all devices marketed under COVID enforcement policies or an EUA to submit and have the FDA accept a complete 510(k) submission within 180 days of the implementation date.
Unfortunately, the FDA guidance documents are often unclear and there are a LOT of unanswered questions.
That’s why we need YOU to leave a comment in the Federal Register by March 23rd to persuade the FDA to adopt some common sense before these proposed plans become law.
PLEASE get involved. Don’t assume “everyone else will.” They won’t.
4 Steps. 5 Minutes. Here’s how:
Download this presentation on the proposed FDA timeline, so you have a solid understanding of what the issues are. (Spoiler Alert: there aren’t really three phases, there’s two)
Download this letter outlining the many concerns we have about the guidance documents and the proposed timeline – edit as needed to reflect YOUR concerns.
STEP THREE: For Devices Marketed Under FDA Enforcement Policies
CLICK HERE to leave a comment, as shown below:
The fields are:
Comment: Please find the attached word document file for the guidance under consideration
Upload File: Click the [+ Add a file] button to upload this word document.
State or Province:
Organizational Name: Can be “self”
Submitter’s Representative: Can be “self”
Category: Device Industry – C0012
STEP THREE: For Devices Marketed Under an EUA
CLICK HERE to leave a comment, as shown below (same fields as above):
Michelle explains why this is important:
+ Michelle and Company +