Carrot Clinical offers consulting services to help organizations with regulatory compliance and quality systems for clinical labs.
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Builds CLIA Labs | Champions Quality | Translates Regulations | Guides LDT Development | Advises Startups
FDA’s final rule to regulate LDTs was just announced. FDA is offering a webinar on May 14th to provide a summary of the rule. https://lnkd.in/gUK4QQvf
Thanks Shannon Bennett for the additional insight on FDA's reclassification announcement. As we get closer to the anticipated final rule in April, it'll be interesting to see what more FDA has in store.
Looks like FDA Law Blog and I are thinking along the same lines. FDA announced this week that they plan on down-classifying many IVDs from Class III to Class II. One can't help but connect this action to the imminent publication of FDA's LDT rule, given that many stakeholders (including me) raised concerns that LDTs by default are Class III today - and no one looks forward to tens of thousands of PMA submissions! Here's their take, definitely worth a read:
Builds CLIA Labs | Champions Quality | Translates Regulations | Guides LDT Development | Advises Startups
20 years ago this month, Genomic Health's (now Exact Sciences) clinical laboratory in Redwood City, CA received CLIA certification and reported the first Oncotype Dx Breast test result. I’m so proud of what we accomplished and honored to celebrate with Stephanie Kernahan Butler, Heidi Cheng (she performed the very first ODx test!), Jerry Hurst, Patrick Joseph and Dean Schorno. As we recognize this magnificent milestone, we also celebrate the countless lives positively impacted by Oncotype Dx. Cheers to two decades of improving the quality of life for cancer patients and making a difference in healthcare. Here’s to many more to come. 🥂 HAPPY 20TH ANNIVERSARY! #OncotypeDx #genomictesting #cancertreatment #precisionmedicine #GHDXers
Builds CLIA Labs | Champions Quality | Translates Regulations | Guides LDT Development | Advises Startups
FDA is hosting a webinar on Tuesday, October 31st (Happy Halloween!) on the proposed rule regarding LDTs. Webinar details are below, including the Zoom link to join the meeting. Registration is not required. #LDTs #FDA https://lnkd.in/gaMb4iGi
Reposting an insightful podcast episode from Mayo Clinic Laboratories that's perfect for those short on time. In just 12 minutes, this discussion provides some background on the FDA's proposed regulation of Laboratory Developed Tests (LDTs) and shares insights on how you can engage and make your voice heard on this crucial issue. Whether you're for or against the proposal, check it out and join the conversation. Your perspective and actions could play a crucial role in shaping the future of LDT regulations. #LDTs #LaboratoryMedicine
In this episode of “Answers From the Lab,” Bobbi Pritt, M.D., chair of the Department of Laboratory Medicine and Pathology at Mayo Clinic, and Bill Morice, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories, discuss the U.S. Food and Drug Administration’s (FDA) recently proposed rule that if finalized, would phase out its current enforcement discretion used for laboratory developed tests, and regulate all laboratory tests as medical devices regardless of where they are manufactured. https://bit.ly/3LKRfYr
ATTENTION CLINICAL LABS: FDA is proposing greater oversight of LDTs through phasing out its general enforcement discretion approach of LDTs.
Today, we announced a proposed rule aimed at helping to ensure the safety & effectiveness of lab-developed tests, which are used in a growing number of health care decisions and for which concerns have been raised for many years. https://lnkd.in/eRb4QAhR
Builds CLIA Labs | Champions Quality | Translates Regulations | Guides LDT Development | Advises Startups
SALSA: legislation that's good for you. Screening and diagnostic tests performed by clinical laboratories inform life’s most important health care decisions. Medicare payment cuts threaten access to clinical laboratory services and undermine our nation’s health care infrastructure. Tell Congress to protect patients and enact H.R. 2377 / S. 1000, the Saving Access to Laboratory Services Act (SALSA). Visit https://stoplabcuts.org to learn more and take action now!