Jennifer L. Brown’s Post

This recent FDA warning letter highlights the importance of appropriate product labelling (RUO versus IUO versus IVD) for the appropriate intended use when you are providing distributed reagents to laboratories. Always have a regulatory expert double check all company labelling-product, web-site, documentation, etc. to ensure there is no misbranding! Boudicca Dx. is here to help with all things IVD. " Your firm’s website also includes the statement that these devices are “For Research Use Only. Not for use in diagnostic procedures.” But, as discussed in this letter, on numerous occasions your iPLEX HS Colon Panel and your MA4 were not being shipped or delivered for an investigation (21 CFR 809.10(c)). And these devices were not for use in the laboratory research phase of development but rather were represented as effective IVDs (21 CFR 809.10(c)(2)(i))." https://lnkd.in/eVpDnAuM

On May 6, 2024, the #FDA published its highly anticipated final rule, revising the regulatory definition of an in vitro diagnostic (#IVD) product to explicitly capture IVDs manufactured by #laboratories.  This makes FDA’s position clear that #LDTs are subject to regulation as, at a minimum, devices. In this article, the team from Arnold & Porter: Mahnu Davar, Philip Desjardins, Abeba Habtemariam, and Phillip V. DeFedele take a deep dive into what the final rule means for clinical laboratories with an overview of the current state of affairs. #clinicallaboratories #laboratorydevelopedtests #medicaldevice #medicaldevices #invitro https://lnkd.in/eGsJREip

A Terrific Summary of the #LDT Rule From Sidley Austin LLP Below: The Impact on #RareDiseases Cannot Be Overstated As a rare disease patient, this #laboratory developed test rule is very disturbing. It has a substantial likelihood of both increasing the cost of and delaying the development of rare disease patient diagnostics. But the impact doesn’t end there—It’s a huge threat to rare disease research and drug development. What Does the Rule Do?: It subjects many #LDTs to new regulation where those tests have previously not been subject to costly and time consuming #clinicaltrial and other burdensome #FDA regulatory requirements. Why the Rule Is So Important in the Rare Disease Space: The development of these diagnostics will be significantly impeded by this regulation. LDTs are critical to: 1) rare disease treatment development, including the design of trials and #CTR participant identification, 2) the successful (and timely) navigation of the #FDA drug approval process, by helping to show efficacy in the target population, 3) identifying coverage criteria that meet #insurancepayer concerns adequately to pave the way for reasonable coverage, and 4) providing #patientaccess to patients post-approval by permitting the identification of the full population needing treatment. Folks, this is a really big deal and a really big problem. #drugdevelopment #orphandiseases #orphandrugs #patientsfirst #clinicallabs #clinicallaboratories #clia

A reminder and cautionary PSA to genomics/omics assay product manufacturers about regulatory compliance and ensuring "your product labeling, marketing materials, advertising, and contractual relationships do not suggest that an unauthorized IVD is actually intended for clinical diagnostic uses". #RUO vs #IUO vs #IVD "Firms offering RUO/IUO IVDs should not: - Use product descriptions or claims that relate to clinical or diagnostic uses - Discuss how the product supports the identification, diagnosis, or monitoring of specific diseases or conditions - Make claims relating to accuracy or performance in a clinical setting or practice - Compare utility to diagnostic tests or to cleared or approved medical devices - Claim that the product may be used as part of an LDT or offer services relating to the development or validation of an LDT" #biotechproductmanagement #biotechmarketing #compliance #diagnostic #LDT #regulatory #genomics

Under the Final FDA LDT rule, LDTs may incur significant new costs to comply with specific quality system requirements, such as design control, and will require the regulatory burden of LDT submission to the FDA for approval as an IVD. Sample collection devices are a critical preanalytical input into your clinical laboratory test system. As a leading provider, DNA Genotek Inc. is here to answer your questions and to help navigate the complexity of the new rule. Read this Q&A with Trace Custer SVP Quality and Regulatory, learn how our expertise and data can support you in qualifying FDA-cleared sample collection devices in your laboratory workflow and support your FDA compliance. https://lnkd.in/g_2QW6Ax

The LDT Final Rule was viewed by many in the in vitro diagnostics space as a costly burden. Navigating FDA premarket review, oversight, and quality compliance isn't easy. But using the LDT pathway to go fast and break things, as companies like Theranos once did, is not sustainable. Particularly as IVDs advance in their complexity, personalization, novelty, and influence on critical healthcare decisions. The good news is that there are genuine market incentives for pursuing an FDA submission. The FDA can play an important role in enabling differentiation, uptake, and product-specific coverage for IVDs with superior clinical evidence. This white paper includes case studies demonstrating these market access benefits for those IVD developers that decide to proactively pursue FDA approval.

While the recent FDA Final Rule related to In Vitro Diagnostics and Laboratory Developed Tests has sparked concerns around enforcement risk, cost, and compliance burden for manufacturers, in our latest whitepaper we also highlight the hidden market access opportunities for IVD developers that are quick to adapt. Our experts Nayan Ghosh & Emma Feinerman draw parallels to a similar guidance around in vitro companion diagnostics released a decade prior, when companies like Foundation Medicine & QIAGEN saw favorable, product-specific coverage determinations by proactively pursuing FDA premarket review ahead of their LDT competitors. Request a full copy here: https://lnkd.in/eptbRN73

Jane Koo, PhD, CTMC's Head of Regulatory Affairs, sat down with Alexandra P. with PharmaVoice to share a few recommendations when working with the FDA: - Demonstrate consistent attention to patient safety at all stages of development and manufacturing - Stay on point and do not provide unnecessary information - Think about CMC early and often to avoid delays - Pre-IND meetings are beneficial to discuss potential challenges and form strategies so take advantage of these opportunities Excellent suggestions from Jane who has assisted CTMC and its partners in clearing 7 INDs in two years. #biotech #lifesciences #regulatory #celltherapy #endcancer https://lnkd.in/gBpNEC8w

Diversity in Medical Device Clinical Trials Most discussions about the lack of diversity in clinical trials are focused on studies for drugs and biologics, not much is discussed publicly about the diversity of trial participants in medical device clinical trials. This week the FDA started publishing the “Device Trial Participation Snapshots” which shows important demographic trends for medical device clinical trials. Read More: https://lnkd.in/gyg6veVH Author: Dr. Mukesh Kumar, PhD, RAC, | CEO, FDAMAP #fda #medicaldevice #drugs #biologics #clinicaltrials #clinicalstudy #clinicalresearch #clinicaldevelopment #fdaregulations #fdacompliance

Join Emergo by UL's webinar to learn best practices for engaging with the US FDA on Human Factors Strategy. When? Thursday July 11th, 3 pm (UK time) In this webinar, my colleagues Allison and Andrea will discuss what to expect during interactions with the FDA, how to prepare for meetings, and how to respond to FDA feedback. Use the link below to register! https://lnkd.in/g9YYBQsX #FDA #HumanFactors #MedicalDevices #Pharma #Combinationproducts