Need to Ease Your Pain on LDTs? We’ve Got It Covered

By Bob Croce

For The Executive War College

Most of us remember the somewhat schmaltzy (yet always loveable) movie “Field of Dreams” from 1989, a film that reminds me of the reputation we have at the Executive War College for bringing clinical lab and pathology leaders the latest in cutting-edge topics and noteworthy speakers. 

Although it’s not a voice from his cornfield, EWC master and commander Robert Michel first thinks, “build it and they will come.” Then, he starts thinking, “ease their pain,” as he goes about creating that year’s agenda behind his desk in Texas Hill Country.

It’s in that spirit today that I humble brag about the type of session that typically springs from Robert’s ultimate goal. After all, what could be more painful than trying to cope with how your lab or lab company complies with a little old outfit called the US Food and Drug Administration (the “FDA” to those who prefer acronyms)?

To talk about the latest on the laboratory-developed tests (LDTs) proposed rule, to ISO 13485, and other things in between, we have tapped Tim Stenzel, MD, former Director of the FDA’s Office of In Vitro Diagnostics to speak at this year’s conference.

Dr. Stenzel’s talk and Q&A is entitled, “New Developments at the FDA: Draft LDT Rule, Harmonization of ISO 13485, Memo on Reclassification of Certain Assays, and More.” (Session day and time, TBD).

Tim Stenzel, MD,
former Director of the FDA’s Office of In Vitro Diagnostics.

Of particular interest when it comes to the info and the Q&A that will follow, will be LDTs, with it’s soon-to-be-published final rule.

Up until now, the FDA has not actively regulated most LDTs. The FDA defines an LDT as an IVD test that is “designed, manufactured, and used within a single clinical laboratory certified for high complexity testing under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).”

The FDA comment period for the new proposed rule on LDTs, which closed on December 4, 2023, received a whopping 6,700 plus comments during the three-month comment period. The FDA will consider those comments as it moves toward a final rule, but until then you need to be prepared and Dr. Stenzel will give his perspective.

To give you an idea of some of what was offered during the comment period, here’s what our friends at the American Clinical Laboratory Association wrote: the “proposed rule would have dramatic implications on access to patient care, the cost of health services, future innovation in diagnostic testing, and numerous other issues” as well as “raise significant legal considerations.”

The final rule will come down quickly following the comment period, since word on the DC street is that the current Administration wants it to go final before November’s election. In fact, we may even get word onsite in New Orleans in April that the rule is a go.

That’s it for this week. More dispatches to come. Hope to see you and your “krewe” in New Orleans.

(Bob Croce is Executive Publisher/General Manager of The Dark Intelligence Group, the company that brings you the Executive War College. Have a question or comment for Bob, you can reach him at

Birds of a feather, flocking together.
Can’t wait to see all of our clinical lab and pathology colleagues in Nawlins!
A scene from our EWC 2023 welcome reception.


(Here are some recent additions to the EWC ’24 agenda)

Speaker: Tim Stenzel
MD, former Director,
Office of In Vitro Diagnostics, FDA

Speaker: Daniel Anderson
Lab Manager, Intermountain Health, Salt Lake City, UT

Speaker: Lisa DanielMLS (ASCP) BB,
Director Corporate Lab Services, Parkview Health
Ft. Wayne IN

Speakers: Linda McHale
Asst. Vice President, Lab Operations, ACL Laboratories, Advocate Health,Charlotte, NC; Shikha Dharamrup, Director of Lab Operations, ACL Laboratories, Advocate

Speaker: Brad BosticCEO, hc1 Indianapolis, IN

For ongoing updates, check out our agenda page.

Hear below what attendees had to say about EWC in 2023