James Mullally’s Post

The article summarizes the pros and cons for the LDT rule from very high level and doesn’t necessarily talk about what in the rule making will specifically affect patients. A discussion at AMDM annual meeting provided more detailed argument both from LDT folks side and from industry side. The general consensus was that LDT folks think this rule will affect access and innovation and industry thinks it will level the playing field. Whichever side you are on, you cannot argue you are 100% right. Both sides will acknowledge there is bad data on both sides. There are erronious LDT’s and there are extremely useful ones. I think taking the bad ones out and leaving the god ones in circulation requires some common evaluation criteria (yet to be defined by FDA or CMS). The current rule does not do that, YET. However, grandfathering in existing LDT’s and allowing them to stay in the market while being evaluated for safety and effectiveness is a step no one thought FDA was for, based on thenpleasently surprised response atleast one LDT guru (oracle of all things FDA and LDT) I assume based on his comments. So best thing to do is to wait for details from FDA. Mind you this biased view is coming from a person working in the regulated industry. #LDTrule, #FDA

Does your facility use lab-developed tests for diagnostics? The FDA says that future development of these tests will be subject to its approval, a major departure from previous regulations that put these tests under CLIA and CMS. What will this mean for your lab? The article below from MedPage Today gives more details. MedPage Today: https://lnkd.in/epTSDwYn #laboratorymedicine #MLT #LDT #FDA #CLIA #CMS

A good summary of the 500 page FDA preamble to their final rule related to laboratory developed tests (LDTs). The section related to "existing LDTs" prior to the final rule is interesting, if accurate. In any event, SLP has the laboratory diagnostic experience to expertly address changes to LDTs as necessary.

Looking to learn even more about FDA's recently issued proposed rule and policy for oversight of laboratory developed tests (LDTs)? Check out Part II of our Insight series, where we provide our full analysis of FDA's proposed five-stage phaseout policy and the open questions that remain. #LDTs, #FDA, #GoodwinLaw https://lnkd.in/gtf9_Dsw

The proposed FDA regulation for laboratory developed tests (#LDTs), as outlined in FDA-2023-N-2177-0001, marks a significant step toward the FDA trying to standardize oversight for these diagnostic tools. In this article, Erika Roberts, MFS, principal consultant and owner of ELR Lab Services LLC, provides a few highlights of comments that illustrate the main themes of the comments: both for and against the new regulation, along with pleas for longer public comment time. This snapshot of public sentiments about this proposed regulation should alert many laboratories to the need to keep up to date on changing regulations that could impact routine testing of patient samples and how they are regulated. #fda #regulation #compliance #medicaldevice #meddevice #labdiagnostics https://lnkd.in/e-Jn7GcC

Emergo by UL’s second Regulatory Update on #RAPSConvergence 2023. This time we share details about the European In Vitro Diagnostics Devices Regulation (Regulation 2017/746, IVDR) with our expert Ken Pilgrim. Read about the IVDR and Clinical Evidence Requirements: https://lnkd.in/ggqCcPN8. We specifically discuss clinical evidence because it is the number one non conformity from IVDR reviews (data from the notified body BSI, presented by Suzanne Halliday, MSc. D.Phil, BSI, 4 October). Thank you to our marketing team for supporting our regulatory updates: Stewart Eisenhart, Kathy Burke, and Khalid Mandil. #medicaldevice #regulatory #regulatoryaffairs #regulatorycompliance #ivdr #clinicalevidence #EmergobyUL #weareULSolutions #welovewhatwedo #weloveglobalregulatory

Very important to read

On September 29, 2023, the FDA announced their proposed rule, “Medical Devices; Laboratory Developed Tests.” The rule, if finalized, would amend the FD&C Act such that laboratory developed tests (LDTs) would be regulated as medical devices. LDTs are not new territory for FDA to navigate and the debate on whether they should continues! Comments to the proposed rule are due December 4. Learn more in Kanchana Iyer’s article! https://hubs.la/Q02byn1z0 Navigating the regulatory landscape within diagnostics can be tricky. Contact Halloran to learn the implications and requirements! #FDA #MedicalDevices #LDTs #Diagnostics #IVDs #FD&CAct #VALIDAct

For innovators of LDTs, this webinar may interest you, see below

On April 29, 2024, after more than a decade of debate, Congressional activity, and proposed regulatory action, the Food and Drug Administration (FDA) finalized a rule asserting its authority to regulate laboratory developed tests (LDTs) as medical devices (“Final Rule”). Read more by Crowell's Jodi Goldstein Daniel, Stephen Holland, and Cara Tenenbaum: