Introducing Dx:Revenue - Precision Medicine Intelligence for Business Development Teams

LEARN MORE

FDA’s Draft Guidance on LDT Regulation Released In Full, Plus Guidance on Notification

by

The FDA today released the full version of its draft guidance on LDT regulation, and also its draft guidance covering notification and reporting by LDT developers (the previously released copy of the regulatory guidance was titled “Anticipated Details,” and was pre-released in response to Congressional pressure). The regulatory guidance seems essentially unchanged from the previously released version.

The new guidance covering notification and reporting has some interesting elements to it. The primary focus of the document is to pull LDTs into the same Medical Device Reporting (MDR) requirements as for kit manufacturers. But the more interesting elements come into play where FDA defines the data elements that LDT developers will be required to provide in their notifications to FDA of the tests they are offering.

A notification will be required for each test offered by an LDT developer, and for each test there are multiple types of information required. Among these is the Monthly Test Volume for each test, which will allow FDA to understand the market in unprecedented ways. Notifications will also require each test to be categorized according to a list of Clinical Uses, including diagnosis, prognosis, screening, etc. IVDs are not currently categorized in this way, at least not in ways that are revealed to users through FDA’s databases.

Once FDA has a assembled its database of LDTs I assume that it will make the information publicly available as with 510(k) and PMA tests. How much of the information they share publicly, and when it becomes available, are issues that we are watching with great interest.