National Pharmaceutical Council’s Post

The vast majority of #diagnostictests for #rarediseases are #labdevelopedtests or #LDTs - including most #newbornscreening tests, #genetic tests including #genepanels, #wholegenomesequencing and #wholeexomesequencing, #companiondiagnostics including #biomarkertests, and many #biochemicaltests. For the past 40 + (!) years (since the Medical Device Amendments of 1976), these tests were under FDA's enforcement discretion. #FDA's LDT final rule sets out to change all that. The rule includes narrow exemptions for certain LDTs - including those LDTs that are currently marketed, and those that BOTH address an unmet medical need AND are offered and used in a single health system (whatever that will actually mean, a lot of legal definitions yet to come). BUT, even those exemptions on apply to *some* #regulatoryrequirements such as pre-market clearance or approval (i.e., #510K clearance or #pma). ALL LDTs will have to comply with other requirements including labeling, medical device reporting (#MDR) requirements, and quality system (#QS) requirements around complaint handling. MANY OF THESE REQUIREMENTS ARE SET TO GO INTO EFFECT IN LESS THAN 2 YEARS! Nobody knows exactly how many LDTs are currently offered, which is a big part of the problem - but everyone agrees that there are A LOT of LDTs out there (tens of thousands of them). Webinars such as this one are crucial to help diagnostic labs, healthcare systems, and other key stakeholders navigate these new requirements: two years, thousands and thousands of tests, and a complex healthcare system that for the past 40 + years did not include this kind of oversight ... the challenges are obvious, and time is ticking. What does all this mean for #raredisease patients who need BOTH high-quality, reliable diagnosti tests they can trust AND ready access to these tests; after all, many of our patients already spend 7 years or more on the 'diagnostic odyssey?' Ultimately, time will tell. We at #NORD the National Organization for Rare Disorders are thankful for webinars like this one - but also deeply concerned about how the rule implementation may play out for our community, and what all this may ultimately mean for #raredisease #drugdevelopment (only think about #companion diagnostics and how vital LDTs are to bridge approval of the diagnostic tests there), for #newbornscreening programs, for access to #genetictesting and #precisionmedicine - and, ultimately most importantly, for our patients and their ability to access the #raredisease #treatments they need - when they need them and where they need them.

If you've been following the discussions on the changes to FDA regulations making many LDTs require compliance with the IVD regulations, here is another FDA webinar providing details on achieving compliance.

💲 FDA recently updated user fees for FY 2025 under MDUFA V. Get the highlights from Audrey Skeen on IVDwise. If you haven't yet, subscribe to IVDwise for Regulatory, Quality, and Clinical Insights for IVDs. #FDA #IVD #MedicalDevices #RegulatoryAffairs #CRO #IVDwise

Stage 1 requirements for clinical laboratories who design, manufacture, and use within their institution in vitro diagnostic tests (Laboratory Developed Tests (LDTs)), is approaching (May 6, 2025). We may recall that the US FDA published the Final Rule on LDTs May 6. The manager of the Emergo by UL US FDA consulting portfolio, Sarah Fitzgerald, has reminded us that the US FDA will host a webinar (August 22) to provide these “laboratory manufacturers” with information about complaint management, adverse event, correction, and removal reporting. Details on the webinar and how to join at the scheduled time: https://lnkd.in/gAD_5AMH. This is particularly important for laboratory manufacturers of LDTs who may not be familiar with general FDA expectations related to complaint and vigilance reporting. Additional resources: Regulatory Update on LTDs: https://lnkd.in/g-RNq8be . Webinar, prerecorded (March 28), on US LDT: https://lnkd.in/gCru9cK4 . FDA announcement to classify most Class III IVDs to Class II: https://lnkd.in/gvUKBWMt . FDA Final Rule of alignment of QMS to ISO 13485: https://lnkd.in/gdet8msT . #medicaldevice #regulatory #regulatoryaffairs #regulatorycompliance #webinar #fda #ivd #QMS #13485 #LDT #MDR #EmergobyUL #weareULSolutions #welovewhatwedo #weloveglobalregulatory  

How To Search FDA Registration Number The method for searching an FDA Registration Number varies based on the type of product. The FDA maintains databases for medical device and drug establishment registrations, but there is no online searchable database for food facility registrations. Let’s explore with GOL step-by-Step Instructions to Search for an FDA Registration Number https://lnkd.in/g-CVuPe5

https://zurl.co/g0aW FDA adcomms have come under fire. Here are some suggestions for improving the process (both explicit and implicit).

Here is a great overview of FDA office structure around IVDs and FDA oversight from product development to post market.  It also has a Q&A session.  https://lnkd.in/gDi2uD4u

Miss our webinar on the new FDA regulations for LDTs yesterday? You can watch the full webinar now and learn how MCRA's IVD experts can set you up for success on our website! Tune in now: https://lnkd.in/eW5JETyU #IVD #LDT #LDTs #LDTguidance #FDAguidance #FDAsubmission #QMS #qualitysystems #webinar #MCRA #regulatory #FDAregulatory #clinicalvalidity #clinicalstudy #clinicalresearch #CRO #medtech #biotech

Want to know what's been catching our attention recently? 🔹 The FDA has recently published two harmonized guidelines developed by the International Council for Harmonization (ICH), a group of which the FDA is a founding member. Q2 and Q14 guidelines focus on drug quality, particularly developing and validating analytical procedures essential for ensuring drug quality and consistency » https://lnkd.in/gy5VCy66 🔹 The FDA has released a new draft guidance document on requests for feedback and its Q-submission program. This program enables sponsors to request feedback on medical device programs under development » https://lnkd.in/gJEa6RTp 🔹 The full FDA’s Rare Disease Day 2024 is available to watch on YouTube » https://lnkd.in/gGue7Ekd 🔹 The EPA has unveiled its final regulation on ethylene oxide emission standards, aiming for a 90% reduction in EtO emissions. However, concerns arise regarding potential shortages of medical devices, as it is commonly used for sterilization. HHS Secretary Xavier Becerra stated that his agency is committed to collaborating with the EPA to lower EtO exposure while addressing the risks of medical device shortages. The notice confirms President Joe Biden's readiness to utilize authority that could grant medical device sterilization facilities a two-year compliance exemption to achieve compliance with the rule » https://lnkd.in/es2kUg3E 🔹 A survey conducted within the laboratory industry aimed to assess their views on the potential effects of the FDA's forthcoming final rule on LDTs. According to ARUP Laboratories' survey findings, 71.6% of respondents opposed the rule, while 83.9% believed they would face negative consequences due to its implementation » https://lnkd.in/ghDy74Bn 🔹 A US-based generic drug manufacturer has pleaded guilty to distributing drugs containing an active ingredient sourced from a foreign facility undisclosed to the FDA, which it lacked approval for » https://lnkd.in/ex-V4-Ky ——— Want news roll-ups like this in your inbox? Subscribe to our Insider Newsletter and get handy industry intel and analysis from industry experts and former FDA professionals » https://lnkd.in/gR8ewskj