Making changes to current LDTs – what do I need to report?

Mar 24, 2015 | News

So you've already formally notified the Food and Drug Administration of a laboratory developed test (LDT) for an in vitro device your clinical lab has introduced as required by the FDA. After the initial launch, your clinical lab manager has made a few revisions to the LDT’s intended use, but since you've already officially notified the FDA of its existence, no need to file a new notification, right? After all, the FDA has always been pretty discretionary about its oversight and enforcement of regulations regarding LDTs under the Medical Device Amendments (MDA) of the Federal Food, Drug, and Cosmetic Act.

If you’re presently operating under that assumption, you could be in for some regulatory trouble. Last year, the FDA released a Draft Guidance regarding FDA Notification and Medical Device Reporting to clarify its position on how LDTs should be reported. Under the new Draft Guidance, if “a laboratory makes a significant change to the marketed intended use of an LDT for which they have previously provided notification, the LDT will be considered by the FDA to be a new LDT.”

That means you’ll have to file a NEW notification within six months of when the final LDT Framework Guidance Document was published or before offering the LDT for clinical use if the offer’s made after that 6-month period. This becomes even more important if those changes to the LDT’s intended use increase the device’s risk to patients. Furthermore, the FDA strongly urges labs that make significant LDT modifications to re-submit notification data to inform the FDA about the specific changes made.

If you choose not to inform the FDA of the changes to the intended use of the LDT, your laboratory will fall out of the scope of the FDA’s discretionary enforcement policy regarding registration and listing requirements. Instead, your lab will now be scrutinized under the agency’s stricter normal enforcement approach and required to pay registration fees as well as register each of your facilities with the FDA and list the devices manufactured in each of those facilities. In short, things will become more difficult for you and your clinical lab if you do not file a new LDT notification when you make significant changes to your LDT’s intended use.