📰 The Food and Drug Administration (FDA) seeks input on health equity for medical devices to help shape a potential regulatory approach. This feedback will develop a framework for evaluating when devices should be tested in diverse populations to support their marketing authorization. The FDA's discussion paper is open for comments until October 4th. Learn more in this curated blog 👉 https://ow.ly/vxbt50TeBy5 #medicaldevice #fda
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Medical Device, Emerging Technology, Digital Health Research Quality, Safety, and Regulatory Compliance Expert
Premarket device regulations can be tricky for combination products, but involving regulators early and often prior to clinical trials will absolutely go a long way in clearing up any confusion. Regardless of whether a clinical study is conducted through a drug-led path, device-led path, or biologic-led path, each constituent part must still comply with its own set of reg requirements AND ALSO consider combined risks and requirements. Primary mode of action will dictate the primary path. An integral prefilled product may for instance be approved for trials through a drug path application, and still need to comply with certain elements of investigational devices (perhaps through abbr IDE requirements) in order to demonstrate the safe and effective performance of the device constituent with that drug and that target population. The fun never ends. https://lnkd.in/geqAiy-x
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🔍 Understanding FDA regulation: The ins and outs of medical devices! 💼💉 Join us as we delve into our latest blog post discussing the regulatory landscape of medical devices by the U.S. Food and Drug Administration (FDA). Explore key insights into the FDA's role in ensuring the safety and effectiveness of medical devices, as well as the regulatory requirements and processes involved in bringing these devices to market. 📖 Read more here: https://hubs.la/Q02q76zQ0 Stay informed about healthcare regulations and compliance. Don't forget to subscribe for more informative updates and valuable insights. 👍🔔 #FDAMedicalDevices #HealthcareRegulation #FDACompliance #PauboxBlog #StayInformed
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Our Regulatory experts at #OneMMS can help your organization navigate through these changes.
The US Department of Health and Human Services recently published its semiannual regulatory agenda for Spring 2024 that includes 12 proposed and 10 final rules the FDA plans to propose or finalize in the near future. Joanne Eglovitch reports in Regulatory Focus: https://bit.ly/3SQesvS
FDA's latest regulatory agenda adds proposed rules for pediatric study plans, container closure GMPs
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The medical device industry is rapidly evolving, and navigating the regulatory landscape is essential for bringing new products to market. A critical pathway for many devices is the 510(k)-submission process established by the U.S. Food and Drug Administration (FDA). To know more details about 510 (k)-submission process, please click the below link and follow Maven Scientific Pvt Ltd for more interesting updates and schedule meeting with us. https://lnkd.in/ef7sGBKP #510kSubmission #MedicalDeviceApproval #FDARegulations #PremarketNotification #PredicateDevice #RegulatoryGuidelines #MedicalDeviceIndustry #MarketAccess #AntimicrobialResistance #DeviceClearance
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FDA Published Remanufacturing of Medical Devices: Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff Country: US #FDA #regulatoryaffairs #healthcareinnovation #publishing #guidance #manufacturing #healthandwellness #medicalproducts #US #report #consult
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The U.S. Food and Drug Administration (FDA), Health Canada and the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) have jointly published the "Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles." This document encourages international harmonization and outlines five guiding principles for PCCPs. Access NAMSA's blog post to learn more about how these guiding principles impact medical device developers: https://lnkd.in/djiFK67j #MedTech #MedicalDevices #FDAguidelines #machinelearning
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Big news in the regulatory world: The FDA has issued draft guidance on accelerated approval to better reflect real-world needs and evolving science. If you’re in the IVD or medical device space, changes like these can feel overwhelming...but they’re also a reminder of why having regulatory experts by your side matters. We believe navigating complex and evolving pathways doesn’t have to be a solo effort. Staying on top of changes like this is what we do every day to help ensure trials stay on track. Read more: https://lnkd.in/g67A9TXv By the way, stakeholders can comment on the draft guidance on www.regulations.gov under docket no. FDA-2024-D-2033 until February 4, 2025. #RegulatoryAffairs #FDA #RegulatoryConsulting #ClinicalResearch #CRO #ClinicalTrials #IVD #MedicalDevices
Accelerated approval: FDA revises guidance to reflect revised withdrawal procedures
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👇 It is good to be heard! See below for how to comment on FDA guidances!
📣 Speak up! This is how you can engage with the FDA today! FDA guidances, notices, and rules are published throughout the year, but especially during the spring and fall. With anything recently issued by the FDA, it is important to make sure your thoughts are considered. FDA typically allows 60 days for public input. Below are 3 steps on how to make sure FDA hears your voice during an open comment period. ✅ Step 1) Within regulations.gov, enter docket number if known (e.g., FDA-2023-N-0061) or by keyword into the search bar ✅ Step 2) Refine Document results by selecting “Only show documents open for comment” and navigating to Agency, selecting Food and Drug Administration ✅ Step 3) Once you find your document of interest, select the “Comment” button and type in your comment and hit submit at the bottom of the page Healthcare Innovation Catalysts invites you to explore the links below: Drugs: Dive into the latest drug-related guidance documents https://lnkd.in/dE3jbQXQ CDRH: Explore proposed guidance documents from the Center for Devices and Radiological Health https://lnkd.in/duAuwTaZ. Seize this opportunity to shape the future of healthcare! Your insights matter! #FDA #guidance #commentary #speakup #regulation #publiccomment #healthcare
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Learn more about Finding FDA authorized devices with Predetermined Change Control Plans (PCCPs) in this insightful post by NDA Partners' Expert Consultant, Brendan O'Leary. #ndapartners #medicaldevices #FDA
In December 2022, the Food and Drug Omnibus Reform Act of 2022 provided the FDA with new authority related to the authorization of Predetermined Change Control Plans (PCCPs). A PCCP can enable significant planned modifications to be made to a medical device after the device and the plans to modify the device have been reviewed by the FDA. This post provides a summary of the law, describes how to find devices that have been authorized with PCCPs, lists devices that I found using these approaches, shows the approximate rate at which the FDA has authorized these devices over time based on the search results, and shows the device areas where PCCPs are most commonly used based on the search results. https://lnkd.in/e7jtTmYu
Finding FDA authorized devices with Predetermined Change Control Plans – Brendan O’Leary
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Founder and Principal Consultant @ Lucent Clinical Consulting LLC | Clinical and Regulatory Affairs Expert | Board Member
Of high interest to companies in the AI/ML software as a medical device space, there are several good examples of Predetermined Change Control Plans (PCCPs) to modify the device that are being successfully implemented in partnership with the U.S. Food and Drug Administration. Predetermined Change Control Plans (PCCPs) can enable significant modifications to be made to medical devices that have been reviewed by the FDA. When these pre-planned modifications are made in accordance with a PCCP that the FDA has authorized, the modifications themselves do not require additional review by the FDA and can significantly reduce time to market. #AIML #SAMD #lucentclinical
In December 2022, the Food and Drug Omnibus Reform Act of 2022 provided the FDA with new authority related to the authorization of Predetermined Change Control Plans (PCCPs). A PCCP can enable significant planned modifications to be made to a medical device after the device and the plans to modify the device have been reviewed by the FDA. This post provides a summary of the law, describes how to find devices that have been authorized with PCCPs, lists devices that I found using these approaches, shows the approximate rate at which the FDA has authorized these devices over time based on the search results, and shows the device areas where PCCPs are most commonly used based on the search results. https://lnkd.in/e7jtTmYu
Finding FDA authorized devices with Predetermined Change Control Plans – Brendan O’Leary
boleary.com
