Hi Gary,
If your existing IDE has not yet been closed, consider asking your lead reviewer if continued access might be possible. I don't see current FDA guidance about this on a quick search, but I've done it within the last few years.
The old guidance I have says it applies when there is a public health need, or preliminary evidence that device will be effective and no significant safety concerns. It
takes an IDE supplement with:
1. Justification for extended study;
2. Summary of S & E data and risks posed by the device;
3. Proposed enrollment rate;
4. Clinical protocol; and
5. Progress towards marketing approval.
I seem to recall that some reviewers preferred this be termed an "extended" (or expanded) study, rather than called continued access.
Hope that is helpful!
Best regards,
Ted
--
Theodore (Ted) Heise, PHD, RAC
Vice President Regulatory and Clinical Services
MED Institute Inc.
1330 Win Hentschel Blvd.
West Lafayette, IN 47906-4149 USA
765.463.1633 ext. 4444
http://medinstitute.com
theise@medinstitute.com
Original Message:
Sent: 1/20/2021 10:07:00 AM
From: Gary Syring
Subject: Treatment IDE
Does anyone have experience with FDA approval of a Treatment IDE, submitted after a Class II device IDE approved clinical study of safety and effectiveness is completed and the 510(k) application is in process?
Given the device is a Class II 510(k) cleared to market pathway device, what is the experience with FDA approving a Treatment IDE for a device that will be cleared to market by a substantial equivalence submission?
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Gary Syring RAC
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