Boston MedTech Advisors’ Post

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

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

🎉 The MHRA announces that the first clinical performance study application for in vitro diagnostic (IVD) devices under the EU IVDR in Northern Ireland has been submitted and approved. This marks a significant milestone in the regulatory management of IVDs within Northern Ireland. The MHRA is the Competent Authority for medical devices and IVD devices in Northern Ireland. Under the terms of the Windsor Framework the rules for placing medical devices on the Northern Ireland market differ from those applicable to Great Britain (England, Wales and Scotland). #medicaldevices #brexit #healthcare #compliance #regulatoryaffairs #diagnostics #laboratory #biotech #clinicalresearch #clinicaltrials #MHRA

Digital twins are transforming #clinicaltrials by allowing precise simulations of patient responses, enhancing #trialdesign, and improving regulatory compliance. As agencies like the FDA update regulations to include this technology, the potential for greater efficiency and reduced costs in #drugdevelopment becomes evident. Explore the impact of digital twins on clinical trials: https://bit.ly/483teWd

The much-anticipated FDA Final Rule on enforcement of IVD (in vitro diagnostic) regulations for Laboratory Developed Tests (LDTs) has been released. The rule describes the previously proposed five stages of enforcement over four years and provides updates to the FDA’s enforcement discretion policy for certain IVDs, including LDTs approved by New York State and LDTs validated prior to the publication of the final rule. With the announcement comes many questions and concerns about the future of LDTs and how laboratories will navigate the changes. As a provider of both services and software for a large community of laboratories running LDTs, Velsera is focused on how we can best support our customers during this transition to more stringent regulatory standards while maintaining the highest level of patient care.  If you have any questions on how we can assist you, please leave us a message:  https://lnkd.in/gbgniC7s For more information on this new FDA rule, please visit: https://lnkd.in/eysanFET 

In addition to announcing the final rule for regulating LDTs and IVDs on Monday, the FDA updated and added resources to try and help us work through all this new information: 🔦 The FDA added a new web page (linked below) that provides frequently asked questions (FAQs) related to laboratory developed tests (LDTs). 🔦 The FDA updated their existing web page on LDTs to provide an overview of the final rule (thanks for the quick reference!) and links to additional sources that labs will need to help them implement new requirements. These include information on an upcoming webinar and links for each element that may apply to labs as part of the phaseout policy stages (see "Medical Device Regulatory Resources" section of the page). https://lnkd.in/gjcGCBJg #medicaldevices #healthcare #compliance #regulatoryaffairs #diagnostics #laboratory #biotech #FDA #LDT

Questions regarding the new FDA LDT ruling? Velsera is here to help answer those questions and to provide support needed to ensure you are ready for the upcoming changes. Please reach out to learn more.

Exciting news for the life sciences industry! 🎉 The FDA has announced a final rule aimed at enhancing the safety and effectiveness of laboratory developed tests (LDTs). This rule clarifies that in vitro diagnostic products (IVDs) are devices under the FD&C Act, even when produced by laboratories. In addition, the FDA will implement greater oversight of IVDs offered as LDTs over four years, replacing its general enforcement discretion approach. A significant step towards ensuring quality standards in diagnostic testing. #FDA #Lifesciences #Regulation #LDTs #IVDs

Another update today to FDA's LDT website (which is an amazing website with TONS of FREE information): https://lnkd.in/gzEKngwJ Upcoming webinars added: July 16, 2024: IVD Classification August 2024: Tentative topic: MDRs, Quality System Complaint Requirements, and Recalls Boudicca highly recommends that CLIA labs at a minimum start complying with Phase 1 requirements (ATTEND WEBINAR IN AUGUST IF YOU DO NOT KNOW WHAT THESE ARE YET). Remember, in accordance with: "FDA Regulatory Procedures Manual Chapter 4: ADVISORY ACTIONS", a Warning Letter is not a prerequisite to FDA taking enforcement action. FDA can take enforcement action without necessarily issuing a Warning Letter when a violation is INTENTIONAL or ADEQUATE notice has been given by other means and the violations have not been corrected, or are continuing..... Might as well start getting your Phase 1 documentation together just in case..... Boudicca Dx has SMEs in CLIA LDT development, IVD Quality & Regulatory, and PhD, IVD-trained assay development experts to help CLIA labs comply with these new quality, regulatory & validation requirements or help labs pivot to FDA-authorized tests if available.

🔬 Exciting News from FDA about Laboratory Developed Tests (LDTs) ! 🔬 Today, the FDA has announced its long-awaited final rule on Laboratory Developed Tests (LDTs), marking a significant step toward ensuring patient safety and test reliability in the diagnostic landscape. Here's a quick overview: 📅 Timeline: The FDA will implement a phased approach over four years to regulate LDTs, gradually increasing requirements for test makers to align with other in vitro diagnostics (IVDs). 🔍 Key Phases: 1️⃣ Stage 1: One year from publication – MDR requirements, correction/removal reporting, and quality system requirements begin. 2️⃣ Stage 2: Two years from publication – Expanded requirements including registration, labeling, and investigational use. 3️⃣ Stage 3: Three years from publication – Remaining quality system requirements under 21 CFR part 820. 4️⃣ Stage 4: Three and a half years from publication – Premarket review requirements for high-risk IVDs. 5️⃣ Stage 5: Four years from publication – Premarket review requirements for low/moderate-risk IVDs. 📝 Enforcement Discretion: Certain LDTs, such as 1976-type LDTs, HLA tests, and those within the VHA or DoD, will have carve outs, ensuring continued access to vital tests. 🛠️ Impact: The rule aims to increase transparency, enhance patient trust, and mitigate public health risks associated with inaccurate or ineffective tests. 💡 Next Steps: While FDA will issue guidance to supplement the rule, potential legislative action, like the VALID Act, could further shape the regulatory landscape. 💬 What are your thoughts on the FDA's final rule? Share your insights and let's drive meaningful discussions in healthcare regulation! #FDA #RegulatoryNews #LDTs #IVDs #Healthcare #PatientSafety #PublicHealth #MedicalDevices #RegulatoryCompliance #HealthTech #Innovation #FDARegulation #MedicalResearch #ClinicalTests #HealthPolicy #HealthcareIndustry #FDAUpdate #HealthcareLeadership