Laboratory leaders looking for more clarity on certain aspects of the FDA’s recently published final rule on laboratory-developed tests (LDTs) are unlikely to find it in the agency’s latest guidance document. The new guidance—the third relating to LDTs that the FDA has released so far—doesn’t include any new information for labs but is still a useful resource, according to experts.
“The new guidance document is helpful as it’s a concise summary of the LDT rule,” said Shannon Bennett, a regulatory expert at Mayo Clinic who recently presented a webinar on the new LDTs rule, in an email to G2 Intelligence. “It describes the milestones and targeted enforcement categories, and provides some helpful resources for compliance.”
He adds that key compliance questions remain unanswered:
“For example, I would like to see more guidance on the specific types of adverse events FDA will expect laboratories to report (milestone 1) and guidance on how large health systems will need to register (milestone 2), e.g., by CLIA number, by city, or some other permutation,” Bennett writes. “FDA is providing a webinar on July 16 to discuss test classification, which will be a must-listen event.”
Regulatory expert Julie Ballard of Carrot Clinical, who co-presented the G2 LDTs webinar with Bennett, agrees that the new guidance offers a much more user-friendly, easier-to-navigate version of the final rule, condensing the more than 500-page original into 21 pages.
“While there’s no substantial new information in the guidance, it effectively simplifies and organizes the critical details of the final rule for easier comprehension and application,” Ballard said in an email to G2 Intelligence.
That key information includes which types of tests will be exempt from FDA compliance and which will be subject to it, as well as the five stages of the FDA’s phaseout policy and deadlines for compliance. It also includes a table (starting on page 13 of the guidance) that summarizes the FDA’s compliance expectations for each type of test over those five stages:
Tests where “compliance [is] currently expected”:
- Donor screening tests for infectious diseases and certain blood typing tests
- Direct-to-consumer (DTC) tests
Tests where “compliance [is] generally not expected”:
- Public health surveillance tests
- 1976-type LDTs
- HLA (human leukocyte antigen) tests for transplantation
- Forensic tests
- LDTs manufactured and performed within the Department of Defense (DOD) and Veterans Health Administration (VHA)
Tests where compliance with at least some FDA IVD regulations is “generally expected beginning May 6, 2025″ (stage 1). (See the FDA guidance for requirements for later stages):
- LDTs for unmet needs manufactured and performed by labs integrated in the healthcare system treating the patient
- Currently marketed IVDs offered as LDTs first marketed prior to May 6, 2024, and not modified beyond the scope described in the rule
- Non-molecular antisera LDTs for rare red blood cell antigens
- LDTs approved by NYS CLEP (New York State Clinical Laboratory Evaluation Program)
- Modified version of another manufacturer’s 510(k) cleared or De Novo authorized test within the scope described in the rule
- IVDs offered as LDTs within scope of phaseout policy, but that do not fall within a targeted enforcement discretion policy listed above
For labs new to FDA IVD regulations, this guidance document also includes a list of resources to help them comply with the following:
- Requirements related to complaints, medical device reports, and correction and removal reports
- Registration and listing requirements
- Device labeling requirements
- Investigational use requirements
- Quality system requirements
- Premarket review requirements
Ballard also agrees that, though lab leaders will find this latest guidance useful, “there are still many unanswered questions.”
“While existing guidance documents are helpful, they’re also tailored to traditional IVDs,” she said. “I’m looking forward to ones that apply more directly to LDTs.”
Still have questions on the FDA’s final LDTs rule? For further insight, see our article based on our recent LDTs webinar, which features further analysis and advice from regulatory experts Shannon Bennett of Mayo Clinic and Julie Ballard of Carrot Clinical.
Additional resources from G2 Intelligence and our partner brand, Today’s Clinical Lab: