Jennifer Mascioli-Tudor, MBA, CQA

The regulation of medical devices can be complicated. Recently, the FDA has endeavored to make the process simpler. The FDA’s PCCP initiative provides guidance on the changes companies can make to medical devices without needing to file for approval. These changes can improve the quality of care of the medical devices are able to provide without increasing administrative burden for the FDA. The FDA is currently seeking feedback on their guidelines. While PCCPs are an important avenue for companies to seek change and navigate regulation guidelines, they fail to highlight an important barrier to access for medical devices: cost. For many patients the cost of medical devices renders them inaccessible. However, they can provide significant benefits, including aiding the process of preventive care and wellbeing. Creating a wider range of access and lowering costs must be an important priority for these medical devices to reach the widest range of patients possible. Key questions: 1. What impact do you believe these changes will have on the quality of patient care? 2. What role do you believe regulations should play in the future of medical devices? #FDA #PCCP #MedicalDevice #HealthcareRegulations

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✅ FDA Inspections are coming... can you predict their questions? Medical Device Complaints lead to inquiries, inspections, citations, and recalls. Still using EXCEL for #MDR Complaint Trending? The volume is sky high that it will crash your computer. Try www.riskbased.ai/maude for #vigilance and #trend predictions with Six Sigma x Riskbased AI. #quality #postmarket #fda #raps

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In 2023, 50% of FDA warning letters included all 4 of these categories- poor CAPA Processes, issues with the Complaint Handling for PMS, Insufficient Medical Device Reporting procedures, and problems with the Validation of the Manufacturing Infrastructure with double-digit letters being extended. 7-8 Warning Letters were caused due to Insufficient Supplier controls, Failure to Maintain Record Files, poor Design control processes, and issues with Design Validation & Verification. How important is it for culture to avoid the Cost of Mishires and have fewer wasted resources while increasing compliance to avoid fines and put safe and effective products out in the market for patients? At SSI, in 9+ years our offer acceptance rate has averaged 93%, 54% of candidates have been promoted within 24 months, and they stay 1/3 longer than the industry average for retention. Let's partner on your critical needs positions so we can help you hire for culture! https://lnkd.in/eMCHm28k #FDAWarningLetters #costofmishires #QualityMatters #Medtech #HireforCulture #RiskManagement #TalentManagement

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Checkout our CEO’s recent post on the recent 2024 CDRH Safety Report. TLDR: the report identifies key areas for enhancing medical device safety: → Strengthening postmarket surveillance The FDA is boosting its surveillance capabilities to address device performance issues quickly. Our integration of real-world data can greatly enhance these efforts. → Increasing data transparency, communication, and collaboration The report calls for better data sharing and stakeholder communication, which will help manufacturers meet regulatory expectations and improve adverse event tracking. → Strengthening medical device recall program Updated guidelines and more transparent recall data will help manufacturers reduce safety risks and improve device reliability. We’re committed to helping manufacturers ensure their devices meet safety and industry standards. We invite you to reach out to us to leverage our expertise. P.S. The link to the full report is in the comments. #medicaldevices #healthcaresafety #connectedcare #medtech

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Off-label use of medical devices can lead to serious harm. To ensure safety, the FDA requires manufacturers to address foreseeable misuse under ISO 14971. Human Factors Engineering (HFE) and usability testing are key to identifying and preventing use errors, protecting both patients and users. To learn about the current US FDA human factors and usability guidance, click here: https://bit.ly/4guzx9c #MedicalDevices #HumanFactors #FDA #RiskManagement

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Heading to #SCDM2024 this week? Don't miss Phil Kirsch, DFnet's Director of Quality, as he presents a panel discussion on "Using Standards to Make Clinical Research More Effective." Read more about this panel discussion - https://lnkd.in/gFXBAGjP #SCDM2024 #ClinicalResearch #StandardsInResearch #DataQuality

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FDA released a new draft guidance on pre-determined change control plans (#PCCP) for ANY DEVICE TYPE so that certain device modifications that generally would otherwise require a new marketing submission can be eliminated. FDA will host a webinar focusing on this guidance eon Sept 3. https://lnkd.in/er29-A8d #medtech #medicaldevice #regulation #policy #healthcare

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ECRI weighed in on the FDA Home as a Healthcare Hub Initiative in today’s stakeholder listening session, drawing on decades of experience with accident investigations, medical device testing, and patient safety data analysis. The new FDA initiative re-imagines the home environment as an extension of the healthcare system, encouraging design elements that are adaptive to care delivery in the home, including medical devices and user interfaces. In the meeting, ECRI identified top safety concerns including: the complexity of medical devices, issues with recall processes, and the need for human factors design to account for training needs, tech literacy, varying levels of physical ability, and more. Watch the video of ECRI’s recommendations from our Vice President of Device Safety: https://hubs.la/Q02H_KV10

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Predetermined change control plans are relatively new concept at FDA but have already been included in several dozen device authorizations to streamline FUTURE modifications. Everything from updating Apple's Apple Watch arrhythmia app algorithms to integrating new CGMs and insulin pumps CamDiab's glycemic controller app to adding new "trajectories" and design modifications to SI-BONE's pelvic implant system. These are all examples I discussed in a Market Pathways article (* https://lnkd.in/gY5pZVxD *) on the state of PCCPs at FDA, including some data, and also insights from Medtronic's Yarmela Pavlovic, Epitel's Christopher Phillips, MSHS, RAC, Amazon's CMDA Shilpa Prem and FDA's Jessica Paulsen from the recent Regulatory Affairs Professionals Society (RAPS) meeting. Details and stats on devices that have undergone PCCPs relied directly on Brendan O'Leary's targeted search function and listing: https://lnkd.in/gxiGyvc4 - Brendan is doing yeoman's work re: extracting useful information from PDF files embedded in FDA databases. ALSO: I'm interested in interviewing companies that have gone through a #PCCP process with FDA about the experience and lessons-learned for Market Pathways. If your company fits that description and you're interested, reach out to me! #medtech #digitalhealth #AI #regulations #FDA #medicaldevices

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If you are not happy with the new FDA LDT rule, here is something tangible you can do to help. It takes 30 seconds. In July, the House Appropriations Committee released FY 2025 bill text as well as report language to accompany their Food and Drug Administration appropriations legislation. The report language directs the FDA to halt the implementation of the final rule on LDTs and work with Congress to modernize the regulatory approach for LDTs: "Laboratory Developed Tests.-The FDA's final rule on Laboratory Developed Tests (LDTs) puts forth a proposed regulatory framework that is a significant shift in the way LDTs are regulated and changes expectations for patients, doctors, and laboratories for the first time since the Clinical Laboratory Improvement Amendments Act was passed in 1988 at the risk of greatly altering the United States' laboratory testing infrastructure and reducing patient access to information that informs their healthcare decision making. The Committee directs the FDA to suspend its efforts to implement the rule and continue working with Congress to modernize the regulatory approach for LDTs." As Congress finishes its work for FY 2025, it is imperative that stakeholders state their support for the report language to ensure it is protected in the final appropriations documents. Please join (AMP) and other industry advocates in support of the House Appropriations report language on the LDT rule by completing this form. The deadline to respond is November 12, 2024. https://lnkd.in/gEp-S-7B

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Thirty-six newly established or revised industry standards were released by NMPA on July 10, 2024, to guide manufacturers for type testing, pre-clinical, clinical studies, and regulatory submissions. Significance of Compliance Industry mandatory standards are legally enforced. Decree 739 Regulation on Supervision and Management of Medical Devices, the highest law governing medical device industry in China, mandates that “medical device shall meet the national mandatory standards; if there are no national mandatory standards, they shall comply with the industry mandatory standards”. The industry recommended standards are not legally binding but recommended by regulatory authorities. 🔎 Click the link to learn more details https://lnkd.in/exQqsHXH We take immense pride in showcasing our recent achievements:  🎯 Approval of Class III Glaucoma Treatment Implants: In collaboration with a global frontrunner in ophthalmic diagnostic and treatment products, we secured China NMPA approval for their Class III glaucoma treatment implant devices. Despite facing significant challenges during the approval process with the China NMPA, our strategic acumen and expertise enabled us to utilize foreign clinical data and avoid local clinical trial as well as shorten the testing time to waive certain custom tests.    🎯Approval of Class III Medical Aesthetic Energy-Based Devices: We obtained approval for Class III energy-based devices, three months ahead of the client’s expectation! We avoided local clinical trials, effectively addressed the new requirement of dose-effective relationships and overcame certain deviations from China technical standards.    🎯Approval of Class III Stereotactic Radiosurgery System: After switching to several local agencies during their multi-year registration process, our client found us through word of mouth. We helped the client fill the gaps and the technical testing and obtained the NMPA approval.   These are just a few examples of our success. At CMD, we’re dedicated to pushing boundaries and achieving excellence in the Medtech field.   CMD can help you assess the impact on your new or existing certificates. Schedule a complimentary call with us if you have any questions [email protected] Subscribe our NMPA news roundup https://lnkd.in/eG57rXq to follow updates. #NMPA #Chinamarket #Regularyaffairs #Medicaldevice #IVDs #Guidelines #standards

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There were two important regulatory updates this week 1. Indeterminate Change: FDA Releases Draft Guidance on Predetermined Change Control Plans for Medical Devices https://ap.pn/3Ne8f9G 2. FDA issues guidance on electronic systems in clinical investigations https://ap.pn/3Ym5VnH The U.S. Food and Drug Administration issued a final guidance titled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers. This guidance provides recommendations on the use of electronic systems, electronic records and electronic signatures in food, medical product, tobacco product, and new animal drug clinical investigations. With the evolving use of electronic systems in clinical investigations, FDA is providing this guidance to sponsors, clinical investigators, institutional review boards and contract research organizations to: Update recommendations for electronic systems deployed by regulated entities in clinical investigations and using a risk-based approach for validation; Clarify the applicability of 21 CFR part 11 to real-world data sources submitted to FDA and the applicability of part 11 to clinical investigations conducted outside of the United States; Provide recommendations regarding data collection from digital health technologies used in clinical investigations; Clarify recommendations for the use of electronic signatures in clinical investigations. This guidance finalizes the draft guidance for industry issued in March 2023, titled Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11--Questions and Answers. This guidance supersedes the May 2007 guidance for industry titled Computerized Systems Used in Clinical Investigations. Indeterminate Change: FDA Releases Draft Guidance...

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Quality improvement (QI) systems are the backbone of a successful lab, keeping practices current and patient care top-notch. But setting up a robust QI system is no small feat and means incorporating a cultural transformation. Here’s what that might look like. https://bit.ly/3zEO66o

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Register today for SDRAN's June 2024 Virtual Event: Unlocking the Secrets of an Effective Medical Device Post-Market Surveillance Program: A Deep Dive into FDA Regulatory Requirements, Best Practices and Current Trends 🔗 Registration link: https://lnkd.in/gxC_TRJY 💡Program Topic: In today's rapidly evolving regulatory landscape, staying current on the latest FDA requirements, guidances and technological advancements is more important than ever. Implementing an effective post-market surveillance program for your marketed medical device is crucial for ensuring the ongoing safety, performance, and compliance to regulations in the U.S. market. This webinar will provide a comprehensive overview of FDA regulations governing post-market surveillance requirements, best practices for compliance, and practical strategies for developing and implementing robust surveillance programs. Attendees will gain valuable insights into navigating the complexities of the FDA regulatory landscape, FDA Audit Readiness and leveraging regulatory intelligence and data analysis to enhance and mitigate product and compliance risk. This session will also cover the impact of emerging technologies such as artificial intelligence and big data analytics on post-market surveillance, providing a forward-looking perspective on the future of medical device regulation. 📅 Date: Tuesday, June 25, 2024 ⏲ Time: 6:00 PM- 7:30 PM Pacific Time 📍Location: Zoom 💲Registration Price: SDRAN members ($10 Virtual), for Non-Members ($20 Virtual) Speaker: Jennifer Mascioli-Tudor, Founder and CEO of JMT Compliance Consulting, LLC. With over two decades of dedicated industry experience, Jennifer Mascioli-Tudor has established herself as a seasoned leader in the fields of Quality and Regulatory within the pharmaceutical and medical device industries. Jennifer has progressed through several roles of increasing leadership responsibility, working for a range of small, medium, and large strategic organizations in the medical device industry, such as Johnson and Johnson, Medtronic, Boston Scientific and GE Healthcare. She is now Founder and CEO of JMT Compliance Consulting, LLC. (www.jmtcompliance.com) where she is focused on partnering with small, emerging growth Medical Technology companies to drive Business/Quality/Regulatory strategy and Operational excellence initiatives. She holds a B.S. in Physiology/Chemistry and French from Eastern Michigan University, an MBA, Global Management from the University of Phoenix and is an ASQ Certified Quality Auditor. Jennifer is an Instructor at UC San Diego, teaching courses to support the Regulatory Affairs for Medical Devices certificate program. Join or renew your #SDRAN membership now at https://lnkd.in/gqRxKR7K! #regulatoryaffairs

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FEATURE ARTICLE: Human factors engineering is a critical piece of #meddevice development that improves user experience and is required for regulatory clearance. Eurofins Human Factors MD, LLC | Integrated Computer Solutions, Inc. (ICS) | BlackHagen Design | Flex | MIDI Product Development | Humanfactors Design Works

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🚨 HOT OFF THE PRESSES 🚨 FDA has issued its first guidance related to the recent LDT Final Rule, "Laboratory Developed Tests: Small Entity Compliance Guide". FDA states that they prepared this Small Entity Compliance Guide to assist small entities in complying with the requirements established in FDA regulations as they apply to IVDs, including LDTs. Upon a quick read, the guidance seems to restate in guidance form much of the LDT Final Rule preamble for how FDA plans to implement requirements for LDTs and their expectations for how labs should come into compliance with these. This is a MUCH easier way to digest the preamble. What are your thoughts? Anything enlightening? #medicaldevices #LDT #healthcare #compliance #regulatoryaffairs #diagnostics #laboratory #biotech #FDA

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Recognizing what to expect during a Medical Device FDA inspection enables a medical device manufacturer to effectively prepare. Don't risk costly setbacks during FDA inspections. Join our expert led preparedness course and arm yourself with expert insights and practical guidance to navigate inspections successfully. Register today: https://bit.ly/4bOi48a #medicaldevices #training #FDA #nsflearn

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