Chris Whelan’s Post

Today, the U.S. Food and Drug Administration (FDA) released the 𝗳𝗶𝗻𝗮𝗹 𝗴𝘂𝗶𝗱𝗮𝗻𝗰𝗲 on the 𝗥𝗲𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗶𝗻𝗴 𝗼𝗳 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀, aimed at clarifying the distinction between remanufacturing and servicing activities such as maintenance and repair. This guidance provides necessary definitions to ensure medical devices are maintained safely and effectively throughout their lifecycle. The document is intended to aid industry professionals and FDA staff by clarifying regulatory responsibilities and outlining essential labeling information that should be included to maintain the 𝗾𝘂𝗮𝗹𝗶𝘁𝘆, 𝘀𝗮𝗳𝗲𝘁𝘆, and 𝗲𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲𝗻𝗲𝘀𝘀 of reusable medical devices. An upcoming webinar on 𝗝𝘂𝗻𝗲 𝟮𝟳, 𝟮𝟬𝟮𝟰, will provide further explanations and insights into the implementation of the guidance document. https://lnkd.in/eTjSR8yP 👉 Visit the FDA's official site for comprehensive information. https://lnkd.in/dcBteUv #FDA #MedicalDevices #HealthcareRegulation #MedicalTechnology #RegulatoryGuidance

FDA's final rule on regulation of Laboratory-Developed Tests (LDTs) is drawing a lot of attention from industry, regulatory professionals, and health care providers. See our analysis here!

🔍 The Food and Drug Administration (FDA) has just released the final guidance titled “Remanufacturing of Medical Devices.” Here’s what you need to know: Purpose: The guidance aims to clarify whether activities performed on devices qualify as “remanufacturing.” It provides recommendations for labeling devices intended for servicing over their useful life. Key Points: Understand when an activity constitutes remanufacturing. Comply with existing regulatory requirements for remanufacturers. Ensure labeling reflects quality, safety, and effectiveness. Stay Informed: The guidance was published in the Federal Register on May 10, 2024. For details, see the FDA’s official document attached with this post. Remember, adherence to these guidelines contributes to patient safety and effective healthcare. 🌟 #FDA #MedicalDevices #Regulation #QualityControl #MedicalDevices #HealthcareCompliance #QualityAssurance #RegulatoryGuidance #FDACompliance

FDA Releases Draft Guidance on Tackling Online Misinformation  The FDA has shared draft guidance offering companies flexibility in responding to online misinformation about medical products. Open for comment for 90 days, this draft provides crucial insights into how the FDA will regulate such responses. Key Points: Two Response Types: Tailored Responsive Communications: Voluntary, internet-based messages addressing false, inaccurate, or misleading information. General Medical Product Communications: Broad responses via various channels, including TV, that comply with all applicable requirements. Privileges and Requirements: Tailored communications are exempt from promotional communication requirements. General communications must meet all regulatory standards. Examples: Correctable misinformation includes false claims like "a cholesterol drug causes Alzheimer’s." Non-correctable opinions include personal dissatisfaction, such as "the product didn’t address my symptoms." FDA’s Intent: Help industry promptly and proactively correct misinformation. Ensure clarity and additional flexibility for responsive communications. #FDA #Misinformation #Healthcare #MedicalProducts #Regulations #Pharma #HealthCommunication #SocialMedia #PublicHealth #IndustryGuidelines #FDACompliance Link to article-https://lnkd.in/eF3QcW3F

The FDA has finalized its guidance on communicating scientific information about unapproved uses of approved or cleared medical products. This guidance, pending OMB approval, ensures that such communications are truthful, non-misleading and valuable to health care providers. Drug and device sponsors should carefully review the expanded options for scientific communications that the FDA has recognized in this final guidance. Comments on the collection of information will be received until February 21. Learn more in our latest Eye on FDA update: https://lnkd.in/gqfDqQjh By: Nathan Brown and Olive Lee #FDA #MedicalProducts #HealthPolicy

🔬 Webinar Alert: Wound Care Laboratory Testing Requirements: Your Path to Compliance 🚀 Sponsored content from NAMSA: Are you ready to navigate the complexities of wound care compliance? Join us on July 11th for an in-depth webinar that will arm you with the knowledge to stay ahead in the dynamic field of wound care. 🩹 What You'll Learn: ◾️ The critical role of in vitro testing and the impact of the updated EN13726 standard ◾️ FDA and EU regulatory requirements specific to wound care, with insights from regional auditors ◾️ Strategies for employing the right test methods to accelerate product development and achieve regulatory approval efficiently 📅 Mark your calendar: Date: July 11, 2024 Hour: 10:00 AM US Central Time Don't miss this opportunity to enhance your understanding and ensure your wound healing devices are compliant and effective. ✅ Register now and take the first step towards compliance mastery! https://bit.ly/4c1AIul #WoundCare #LaboratoryTesting #RegulatoryCompliance #MedicalDevices #NAMSAKnows

A Qsub is a cost effective mechanism for engaging with the FDA on clinical elements prior to submission. ABC are well placed to support these critical dialogues. https://ow.ly/BhTi50TOgLp #FDAConsultation #RegulatoryAffairs #ClinicalResearch #HealthcareInnovation #LifeSciences

Just to give a sense of urgency on this...there are 303,010 non-exempt CLIA laboratory entities in the US (https://lnkd.in/enj_-iir) Compliance with the first phase is due in less than a year - May 6, 2025. Phase 1 (of 5) is the first column in FDA's webinar slide below.   We are/have been ready (with immediate solutions-MDR training, supporting documents/procedures, and have extensive experience aligning with FDA through BDDs and Pre-submissions) I suggest getting help sooner from us rather than later given the immense number of CLIA labs and all the tests that they have to take through the FDA authorization process. 

[New Blog] - FDA Stands Its Ground on CDS Guidance The FDA’s guidance for clinical decision support (CDS) programs has proven unusually controversial, leading to the filing of two petitions that the agency withdraw the guidance. However, the #FDA recently reaffirmed its position on the guidance, a position that some have argued conflicts with the 21st Century Cures Act. #LifeSciences

🚀 US Regulatory News: Update from the US FDA 💡 The #FDA has just released its final #guidance on "Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products." 📊This crucial document, part of the Real-World Evidence (#RWE) program, outlines key considerations for using #EHRs and medical #claims data in clinical studies. 👉 Check out the full guidance here: RegTrac provides regulatory partner & support services for #medicaldevices and #invitrodiagnostics. Get in touch with us to schedule a 30-minute free consultation with our experts at [email protected] | www.reg-trac.com #RealWorldData #EHR #RegulatoryAffairs #ClinicalTrials #HealthcareInnovation