RQM+ Weekly Watch #34

RQM+ Recap

RQM+ news, recent content, and upcoming events.

[This Thursday] New ISO 10993-1 Risk Management Framework

[November 21] Master the new ISO 14971 framework application to biological evaluation, understand critical updates to device categorization, and learn implementation strategies for maintaining compliance in our Jordi Labs, an RQM+ Company-focused panel discussion on 21 November. Director of Biological Evaluation Taryn Meade leads our esteemed panel, which also includes Stephen Bond, Amanda DeGraw, MS, PhD, DABT, and moderator, Christine Santagate, RAC.

We hope to see you on Thursday!

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NEW BRIEF ?? Determining the Primary Endpoint in Clinical Research

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Explore our latest technical brief by Cordula Stover, MD PhD, where she breaks down one of the most crucial elements of clinical study design. Whether you're a medical device manufacturer, CRO, or clinical research professional, this practical guide will help you, offering insights that can strengthen your clinical investigation strategy and improve study outcomes.

?? Read the brief and ensure your clinical studies stand on solid methodological ground.

NEW BRIEF ?? Bridging Treatment Gaps in Heart Failure with Reduced Ejection Fraction: Advancing Evidence for Device-Based Therapies

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Heart failure with reduced ejection fraction (HFrEF) impacts millions globally and the treatment landscape is evolving. While guideline-directed medical therapy (GDMT) is foundational, emerging device-based therapies are stepping in to address unmet needs in intermediate stages of care. In his latest technical brief, VP of Global Regulatory Affairs Jaishankar Kutty, Ph.D. explores:

? The clinical and economic burden of HFrEF

? Opportunities for device-based therapies to reshape outcomes

? Strategies for designing impactful trials that secure reimbursement

You'll also learn how RQM+ partners with MedTech innovators to drive adoption of life-changing therapies through evidence-driven approaches.

?? Read the full brief here.

Europe

• MDCG 2023-3 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746 was updated to Rev 1. The update is mostly to add the IVDR to the scope of the Q&A.
• The MHRA have opened another consultation on the UK's medical device regulatory framework, this time focusing on four areas: International reliance, UKCA marking, In vitro diagnostic devices & Assimilated EU law.
• In the UK Uniting the UK's Health Data - A huge Opportunity for Society was published, commissioned by the Chief Medical Officer for England, the UK National Statistician and NHS England's National Director for Transformation.

United State and Canada

• Nothing of note this week!

Rest of World

• ISO released their monthly list of published standards (01 October - 1 November). Of note for the medtech industry are:ISO/TR 8417:2024 Risk management of particulate contamination for devices with intravascular access;ISO 14356:2024 Dentistry — Duplicating material,ISO 25539-3:2024 Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters,ISO 11979-2:2024 Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods,ISO 80369-2:2024 Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors for respiratory applications,ISO 11334-4:2024 Assistive products for walking, manipulated by one arm — Requirements and test methods — Part 4: Walking sticks with three or more legs,ISO 15883-1:2024 Washer-disinfectors — Part 1: General requirements, terms and definitions and tests.

Recalls, FSCAs, and Alerts

Class I Recall (United States)

• Endoscopic Vessel Harvesting System Recall: Getinge and Maquet Cardiovascular Remove VasoView HemoPro 1 and 1.5 Endoscopic Vessel

FDA Safety Communications

• Safety and Availability Concerns with VasoView HemoPro Endoscopic Vessel Harvesting Systems - Letter to Health Care Providers

Other FSCAs / Safety Notices

• FSNs published in the UK: Field Safety Notices: 4 to 8 November 2024

Warning Letters (United States)

• Owens & Minor, Inc. dba American Contract Systems, Inc. MARCS-CMS 695683 — November 01, 2024 [Acceptance Activities; Design Control]

Approvals, Clearances, and Classifications

GORE EXCLUDER Conformable AAA Endoprostheses (EXCC) - P200030/S014 (W.L. Gore & Associates, Inc.)

TruSight Oncology Comprehensive - P230011 (Illumina, Inc)

Simplera system - P160007/S047 (Medtronic MiniMed, Inc.)

UNIPURE SF6 Ophthalmic Gas UNIFEYE Gas Delivery System and UNIPURE SF6 Ophthalmic Gas UNIPEXY Gas Delivery System - P230012 (Alcon Research, LLC)

De Novo Decision Summaries (Updated):

• DEN230092 - Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack & Sample Prep Kit
• DEN230011 - OcuCool
• DEN240016 - Xpert HCV; GeneXpert Xpress System
• DEN220030 - RemeOs? Screw LAG Solid
• DEN240007 - BioHealx Anal Fistula Device

De Novo Classification Order:

• DEN230082 - Stone Clear
• DEN230083 - Valeda Light Delivery System
• DEN230084 - Dexter L6 Surgical System

In the news:

• Advisory Panel Recommends FDA Approve Marketing Authorization For Novel Breast Cancer Treatment
• GE Healthcare’s head-only MRI scanner cleared by the FDA
• J&J’s Ottava surgical robot to begin clinical trial after FDA nod
• J&J wins FDA approval for Varipulse PFA system
• FDA clears Omron blood pressure cuff with afib detection
• FDA approves Caris multi-cancer companion diagnostic test
• J&J gets FDA OK to begin trials for its Ottava surgical robot
• Zeta Surgical to roll out brain surgery navigation system
• FDA approves J&J’s Varipulse pulsed field ablation system

Articles We Read

Note: Some articles are behind a paywall (MedTech Insight) and are clearly noted.

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Europe Related

• MHRA wants feedback on updating IVD, medical device regulatory framework (RAPS)
• Euro Roundup: Commissioner-designate vows MDR action on orphan, pediatric devices in Q1 2025 (RAPS)
• MDCG adds four questions to vigilance terms guidance to comply with MDR/IVDR (RAPS)
• UK Kicks Off Seven-Week Pre-Market Regulatory Consultation (MedTech Insight)
• La French Touch: How France Has Built a Reputation for Excellence In Medtech (MedTech Insight)
• EU Persons Responsible For Medtech Regulatory Compliance: A Tough, Evolving Role (MedTech Insight)
• EU Medtech Association Focuses On Innovation And Digital At 65th Anniversary (MedTech Insight)
• How And Why To Prioritize Governance In Two-Track Medtech Regulatory Review (MedTech Insight)
• EU Regulatory Round-Up: How Medtech Lobbying Altered EU Parliament’s Stance (MedTech Insight)
• The AI Act and EU Medical Device Regulation: how will they work together? (Taylor Wessing)
• The New EU Product Liability Directive (Drug & Device Law Blog)

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United States and Canada Related

• GAO finds persistent challenges in FDA’s ability to hire and retain inspectors (RAPS)
• This Week at FDA: RFK Jr. nominated to HHS Secretary, FDA wants feedback on RWE and patient-focused drug development (RAPS)
• FDA again urges lawmakers for new notification authority, funding to address future pandemics (RAPS)
• Califf ‘disappointed’ about election, warns of changes at FDA (RAPS)
• Experts say RFK Jr. could play big role in Trump 2.0, FDA leadership to face scrutiny (RAPS)
• Kennedy's HHS Nomination Sparks Mixed Reactions in Medtech Sector (MedTech Insight)
• GAO Report Highlights Cybersecurity Threats To Public Health, Offers Fixes (MedTech Insight)
• Staff Changes, New Leadership May Disrupt FDA Under Trump (MedTech Insight)
• Some False Claims Act Enforcement May Cool Under Trump, Lawyers Predict (MedTech Insight)
• FDA Adds Devices To Breakthrough Program, Cardiology Devices Still Out Front (MedTech Insight)
• Michigan Repeal Of Product Liability Protection Is Not Retroactive (Drug & Device Law Blog)
• HISAA: New Legislation Would Bring Cybersecurity Requirements for HIPAA Covered Entities and Business Associates (Health Law Advisor blog)
• Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development (FDA Law blog)
• The Prophecy: How will the FDA under the New Trump Administration Handle OPDP Letters? (FDA Law blog)
• FDA and the Device Industry: Friends or Foes? (FDA Law blog)
• The Trump Transition Explainer: Everything you need to know about how the election of Donald Trump could affect FDA
• Trump nominates RFK Jr. to lead HHS
• FDA breakthrough device decisions rebound after recent declines
• Advamed CEO congratulates Trump, stresses need for public policy support
• How the healthcare industry is reacting to a second Trump term
• What medtech CEOs are saying about Trump's potential tariffs
• Health systems band together to test and publicly rank top AI models

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Global Items / General Industry News

• Creating a Circular Eco-System for Medical Devices: Single-Use vs Reuse (BSI)
• Can Computer Simulations Provide Trustworthy Regulatory Evidence?
• News We’re Watching: Schwarzenegger ZB’s Chief Movement Officer; J&J Ottava Enters Clinical Trials; Dassault, FDA Develop First Guide For Virtual Twins

Stay In the Know

• Visit the RQM+ Knowledge Center for upcoming and on-demand content
• Subscribe to the RQM+ Device Advice podcast (Apple, Spotify)
• Subscribe to the RQM+ YouTube channel
• Follow RQM+ on LinkedIn for regular updates
• See RQM+ upcoming in-person events