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Field Medical wins FDA breakthrough designation for pulsed field ablation system US-based Field Medical has secured breakthrough device designation from the US Food and Drug Administration

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

📢 The FDA has clarified that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act, including those manufactured by laboratories. The agency is planning a phased approach over four years to its enforcement discretion on LDTs, a move that aims to protect public health better and promote innovation within medical communities. 💡 🆕 This approach came after comprehensively considering the comments received to the notice of proposed rulemaking. The ultimate goal is to ensure that the IVDs manufactured by either a non-laboratory or laboratory meet safety and effectiveness standards while minimizing disruption to patient care. 🗞 👀 Increased oversight by the FDA will also promote transparency, ensuring representation in validation studies and assessing potential differential performance and performance in specific patient populations, ultimately paving the way for health equity advancement. 👊 ✍ Stay tuned for a detailed overview of the final rule and phaseout policy through an upcoming webinar hosted by the FDA on May 14, 2024. 📆 👉 For more details, visit - https://lnkd.in/gRTx_z-f #FDA #healthcare #safety #LDTs #innovation #publichealth

Our Regulatory experts at #OneMMS can help your organization navigate through these changes.

Regulatory policies influence the availability of affordable biosimilars, with varying impacts across different jurisdictions. A study compared biosimilar regulations in the EMA, FDA, Health Canada, the MHRA, and the TGA based on their governing laws and regulatory practices. Factors like testing requirements, indication expansion, market exclusivity, and automatic substitution, which can influence the adoption of biosimilars, were further examined. https://lnkd.in/eeBeRrsk

📰 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

Thinking about using Real World Evidence (RWE) to support a regulatory submission in the US? If so, everything you need to know is in this newly released FDA guidance.... https://lnkd.in/geANjjW7

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 

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

🌟FDA's Purple Book: Your Go-To Resource for Biologics and Biosimilars! 🌟 Are you a healthcare professional, industry stakeholder, or simply interested in the world of biologics? The FDA's Purple Book is here to provide you with comprehensive information on licensed biological products, including biosimilars. 🔍 Key Features: - Access detailed information about biologics approved by the FDA. - Explore patent information associated with licensed biological products. - Utilize the user-friendly interface to find what you need quickly and efficiently. 🛠️ How to Check Information: 1. Visit the Purple Book Website: [Purple Book Website](https://lnkd.in/dYH78p5U) 2. Search for Products: Use the search bar to enter the product name or active ingredient. 3. Explore Details: Click on the product to view approval dates, exclusivity, and patent information. 4. Utilize Filters: Narrow down your search using filters for more specific results. Whether you're looking for product names, approval dates, or exclusivity details, the Purple Book is your one-stop resource for all things biologics. 👉 Explore the Purple Book today: Purple Book Website (https://lnkd.in/dYH78p5U) #Biologics #Biosimilars #FDA #HealthcareInnovation #Pharmaceuticals #US #EU #research #kaust #gcc #middleeast #healthcare #pharma