Home 5 Lab Industry Advisor 5 Lab Compliance Advisor 5 Compliance Perspectives-lca 5 Which Recent FDA Webinars Are Most Useful for the LDT Rule?

Which Recent FDA Webinars Are Most Useful for the LDT Rule?

by | Jan 22, 2025 | Compliance Perspectives-lca, Essential, FDA-lca, Lab Industry Advisor

Regulatory expert Julie Ballard shares her thoughts on the most useful resources for labs as they get ready to comply with Stage 1

To assist clinical laboratories with the implementation of the newly adopted U.S. Food and Drug Administration (FDA) rule regulating laboratory-developed tests (LDTs), the FDA has hosted several recent webinars. But what information from these webinars will be most useful for labs as they prepare for compliance? Lab Industry Advisor recently connected with regulatory expert Julie Ballard, CLS, MLS(ASCP), and principal of Carrot Clinical, for her thoughts.

Ballard has been educating diagnostic laboratories regarding the LDT final rule since the FDA first announced its intentions to oversee LDTs. She builds new Clinical Laboratory Improvement Amendments of 1988 (CLIA) certified labs, guides LDT development, and is a quality and regulatory specialist.

Recommendations gleaned from the FDA webinars

When the LDT final rule was first published, the FDA’s initial webinars were broad, simply focusing on outlining the general requirements and explaining the phased-out plan of enforcement discretion, Ballard says. While she believes these early webinars were useful for laboratories to gain a high-level understanding on the topic, she adds that the lab community was oftentimes left with more questions than answers because of the vague information provided by the FDA. However, recent webinars have become more pragmatic, she says, highlighting three that she found to be most helpful as they provide tangible steps and instructions that labs can concretely follow:

August 22, 2024, webinar: MDR principles, corrections and removals, FEI numbers

Ballard has found the most insightful FDA webinars to be those that dove into specific, practical aspects of compliance with the LDT final rule. These include the guidance on Medical Device Reporting (MDR) principles, as well as those relating to corrections and removals and the reporting of such to the FDA, from the August 22, 2024, webinar.1 That presentation also offered information on how laboratories can obtain an FDA Establishment Identifier (FEI) number, which is included as part of the MDR mandates.2

September 24, 2024, webinar: 21 CFR 809.10(b) labeling requirements

The FDA’s September 24, 2024, webinar is also one lab leaders will want to make note of as it focuses on complying with labeling requirements for test systems under 21 CFR 809.10(b).3,4 Ballard says this presentation was helpful because the FDA utilized “real-life examples of FDA approved LDTs when explaining [these] labeling requirements.”

December 3, 2024, webinar: registering IVDs

In a broadcast on December 3, 2024, the FDA offered a step-by-step process for registering in vitro diagnostics (IVDs), including LDTs.5 The FDA’s explanation of the differences between single and multiple sites was particularly illuminating, Ballard says.

What additional resources are available to labs?

Because they have worked to improve their communication and have been offering more practical guidance on compliance with the LDT final rule, Ballard is encouraging her lab clients to engage with the resources and webinars provided directly by the FDA. First and foremost, she is advising her clients to understand and prepare for implementation of the Stage 1 requirements for the phased rollout of the rule. This phase will go into effect on May 6, 2025, and require laboratories offering LDTs to comply with MDR, correction and removal reporting, and quality system requirements concerning complaints.6

Besides the FDA’s resources, there are other places where laboratory leaders can find additional education on the LDT final rule. In a lawsuit filed in late May 2024, the American Clinical Laboratory Association (ACLA) challenged the FDA’s authority to issue and enforce the rule allowing the agency’s regulation of LDTs, and the Association for Molecular Pathology (AMP) also filed a lawsuit against the FDA for the same reason. Both groups argue that the FDA has exceeded its authority in issuing the rule and in its plans to enforce it.7,8

Ballard says she has found online resources that provide updates on the pending litigation from the ACLA and AMP cases “particularly insightful.” She mentions that, oftentimes, we only hear about the initial filing of a court case and then learn of its ultimate outcome, sometimes months or years later. However, social media and online engagement has allowed the lab industry to stay abreast of news regarding these lawsuits throughout the cases’ life cycles. She recommends following trusted regulatory leaders in the lab industry space that post public updates and participate in educational presentations, like Christine Bump, principal and founder of Penn Avenue Law & Policy.

Ballard notes that, even if the LDT rule is completely squashed by the incoming government administration, which expert consensus suggests is unlikely, laying the groundwork for top-notch compliance by preparing for the rule’s implementation is “still valuable for maintaining and improving the quality of LDTs. The effort put into meeting these requirements will not be wasted, regardless of any effect the changing administration may have on the final rule,” Ballard says. These preparation efforts will lead to “improved quality, documentation practices, and safety monitoring, all of which benefit [both] the lab and its patients in the long run,” she adds.

Final recommendations

Staying in the know about industry updates relating to the LDT final rule, including those directly provided by the FDA, as well as from other trusted regulatory resources, are the best ways laboratories can prepare for compliance with Stage 1, as well as later stages of the rule’s implementation. These are all free resources available online, and it is in the best interest of clinical laboratory leaders to familiarize themselves with and continue following these sources of valuable information.

References:

    1. https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-in-vitro-diagnostic-products-ivds-mdr-requirements-correction-and-removal-reporting

    1. https://www.fda.gov/media/131911/download

    1. https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-labeling-requirements-in-vitro-diagnostic-products-ivd-including-ldts-under-21-cfr-80910b

    1. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-809/subpart-B/section-809.10

    1. https://www.fda.gov/medical-devices/cdrhnew-news-and-updates/webinar-registration-listing-requirements-in-vitro-diagnostic-products-ivds-including-laboratory

    1. https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests

    1. https://www.acla.com/acla-challenge-to-fdas-final-rule-regulating-laboratory-developed-testing-services-as-medical-devices/

    1. https://www.amp.org/AMP/assets/File/pressreleases/2024/AMP_FDA_%20Suit_8_19_2024_FINAL.pdf?pass=39

Subscribe to view Essential

Start a Free Trial for immediate access to this article