RQM+ Weekly Watch #32

RQM+ Recap

RQM+ news, recent content, and upcoming events.

Just-Announced: Critical Shifts In Biological Evaluation Panel ??

[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 in a little over two weeks!

?? Learn more and join live ???

Laboratory Developed Tests: Current State of Play FAQ

Legal challenges to FDA 's regulation of Laboratory Developed Tests will see court decisions by Q1 2025, just before the first compliance deadline. With additional uncertainty from the presidential election and potential congressional action, laboratories are advised to prepare for compliance now rather than await legal resolution. Read the entire FAQ-style technical brief written by Director of IVD Global Regulatory Affairs, Margot Borgel, Ph.D.

?? Read the Technical Brief Now ??

In-Person Events

See the complete list here. ??

Featured Event ? If you want to learn about the newest developments for regulatory, clinical evidence, and market access - and to discuss these topics in-person with some of the utmost experts in the field – Horizon 2024 is fast approaching. Amie Smirthwaite, PhD, FRAPS is chairing the 20-21 November conference in Copenhagen and has brought together highly experienced experts from notified bodies, industry, and consulting. Attendees will experience a fully-packed and interactive program (nine sessions) over two days and nine sessions.

Europe

• MDCG updated to MDCG 2022-5 to revision 1. Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices and published MDCG 2024-13 Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices . Both are on the subject of the classification of EtO gas used for the sterilisation of medical devices and help clear up some potential confusion on whether EtO gas itself should be classified as a medical device under the EU MDR (Answer = it depends!).
• The Commission also published a Q&A document in relation to the new Article 10a added to the EU MDR and IVDR during the most-recent amendments.?
• The agreed text of resolution of the European Parliament on the ‘Urgent need to review the medical devices regulation ’ has been released. And in response (presumably) to those various conversations regarding the above proposals for the revision of the EU MDR and IVDR, Team-NB have published a press release with their views on implementation of those regulations . And MedTech Europe have responded to the agreed text of the Parliament's resolution: MedTech Europe reaction to the European Parliament’s Joint Motion for a Resolution on the urgent need to revise the Medical Devices Regulation . As have COCIR: Urgent measures needed to ensure the availability of medical technologies in Europe
• The EMA/Expert Panels published their advice to the MDCG in relation to paclitaxel-coated balloons and paclitaxel-eluting stents . For more specific thoughts on this advice, read Dr Jai Kutty's LinkedIn post here .
• The Commission opened a consultation on draft implementing regulation relating to the joint scientific consultation, as part of Health Technology Assessments, on medical devices and IVDs: COMMISSION IMPLEMENTING REGULATION (EU) …/... of XXX laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medical devices and in vitro diagnostic medical devices. The consultation closes on 26th November 2024.
• GMED's latest newsletter outlines the requirements of Article 16 in both the EU MDR and IVDR .
• For the UK, the MHRA's most recent blog has outlined some milestones both achieved and to come. Probably of most interest are the 2024 and 2025 timings for the release of drafts of what is being referred to as the ‘pre-market SI’ that will be the main change to the framework of the current UK MDR 2002.
• Also in the UK, the MHRA have worked with the Health Research Authority (HRA) to develop guidance aimed at increasing the diversity of people taking part in clinical trials and clinical investigations . The consultation on the draft closes on 9th December 2024.
• And again in the UK (missed from the last edition of this news post), the UK's Department of Health and Social Care (DHSC) has published its 'Design for Life' strategy , a comprehensive 20-year roadmap aimed at transitioning the HealthTech sector towards a circular economy by 2045. This strategy sets out the UK government’s ambition to transition away from all avoidable single-use medical technology products and move towards a functioning circular system by 2045, through maximising reuse, remanufacture and recycling efforts.
• And the UK's NICE published draft guidance recommending the use of 4 AI technologies to help professionals detect fractures in urgent care settings .

United States and Canada

• MITRE published a whitepaper on Data Normalization Challenges and Mitigations in Software Bill Of Materials (SBOM) Processing .
• The Consumer Technology Association (CTA) published Best Practices and Recommendations for Information Disclosure (CTA-2125) , which identifies best practices and content recommendations to inform users about the data and governance used to develop Artificial Intelligence (AI) or Machine Learning (ML) systems through the use of Information Disclosures.

Rest of World

• World Medical Association updated the Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Participants .

Recalls, FSCAs, and Alerts

Class I Recall (United States)

• IPV Therapy Device Recall: Percussionaire Removes Certain Phasitron 5 Breathing Circuits Due to Risk of Nickel Exposure
• Incubator/Warmer Correction: GE Healthcare Updates Use Instructions for Giraffe OmniBed and Giraffe Omnibed CareStation due to Risk of Heater Door Falling and Causing Infant Injury
• Air Compressor Device Correction: GE HealthCare Provides Updates to EVair Compressors Due to Final Formaldehyde Testing Results
• Tracheostomy Tube Recall: Smiths Medical Removes BLUselect, BLUgriggs, and BLUperc Tracheostomy Tube Kits due to Potential Disconnection of Pilot Balloon
• Assistive Arm Correction: Kinova Issues Correction for Jaco Assistive Robotic Arm due to Fire Hazard and Burn Risk
• Ventilator Correction: Baxter Healthcare Updates Use Instructions for Life2000 Ventilation System Due to Risk of No Low Gas Pressure Alarm

FDA Safety Communications

• Update: Use of GE HealthCare EVair and EVair 03 Compressors - Letter to Health Care Providers .
• Update: Do Not Use BioZorb Marker Implantable Radiographic Marker Devices: FDA Safety Communication

Other FSCAs / Safety Notices

• FSNs published in the UK: Field Safety Notices: 14 to 18 October 2024 ; Field Safety Notices: 21 to 25 October 2024 ; Field Safety Notices: 30th October 2024

Warning Letters (United States)

• None.

Approvals, Clearances, and Classifications

De Novo Classification Order

• DEN230076 - Omron Blood Pressure Monitor with AFib Detection Feature
• DEN230078 - Versius Surgical System
• DEN230087 - AMStent? Tracheobronichial Covered Stent System

De Novo Decision Summaries (Updated):

• DEN220009 - VerTouch Spinal Imaging Device
• DEN220066 - BrainSee
• DEN230006 - esolution? Esophageal Retractor
• DEN230011 - OcuCool
• DEN230032 - Symani Surgical System
• DEN230064 - BraidE Embolization Assist Device
• DEN240017 - ShortCut
• DEN230023 - Rho
• DEN230034 - X100 with Full Field Bone Marrow Aspirate (BMA) Application, X100HT with Full Field Bone Marrow Aspirate (BMA) Application
• DEN230045 - Sonu
• DEN230055 - FSYX??Ocular Pressure Adjusting Pump System

Articles We Read

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

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Europe Related

• Medtechs Applaud UK Life Sciences Fund But Seek Lowering Of ￡8M Project Threshold (MedTech Insight)
• Commission’s Newly Proposed Consultation Process Offers Bonus For Innovation (MedTech Insight)
• EC Releases Document On Device Shortage Reporting Obligations (MedTech Insight)
• Hospital Equipment Spending Gets A Boost In UK Budget (MedTech Insight)
• Nordic Medtech Experts Urge More Collaboration On Health Technology Assessments (MedTech Insight)
• European Parliament Wants EC’s MDR Revision Proposals By End Of March 2025 (MedTech Insight)
• Germany: Two-Thirds Of Medtechs Rate EU Regulatory System Below FDA’s (MedTech Insight)
• EU HTA Regulation: Assessors Risk Exclusion for Secrecy Breaches (MedTech Insight)
• Swiss Medtechs Eye Near-Term Regulatory Progress On EU And FDA Fronts (MedTech Insight)
• ‘Unicorn’ Startup Owkin On EU’s AI Act, Funding Needs: ‘Europe Doesn’t Want To Be Under-Competitive’ (MedTech Insight)
• European Commission Receives Contradictory Messages Over MDR Revision (MedTech Insight)
• EMA proposes updated guideline on peripheral arterial occlusive disease treatments (RAPS)
• Euro Roundup: Commission seeks feedback on medtech joint scientific consultations (RAPS)
• European Commission Q&A details shortage reporting requirements under MDR, IVDR (RAPS)
• Notified body official shares recommendations for successful PMCF plans (RAPS)
• Expert discusses how to avoid clinical evaluation derailments for medical devices (RAPS)
• MDCG clarifies how ethylene oxide is regulated under MDR, IVDR (RAPS)
• EU Parliament passes resolution citing ‘urgent need’ for MDR/IVDR revision (RAPS)
• EMA official reports on scientific advice pilots for high-risk and orphan devices (RAPS)
• Expert discusses implications of EU AI Act ‘high risk’ provisions on medical devices (RAPS)
• Euro Roundup: Britain proposes postmarket surveillance law in first major update to medtech regulations (RAPS)
• Stakeholders disagree over need for ‘urgent action’ on MDR/IVDR (RAPS)
• Irish Medtech call for EU regulatory reform as leaders gather in Galway
• Search and rescue: Save yourself from the most common SaMD literature search and review mistakes (Scarlet)
• The EU's AI Act: What It Means for the Medical Device Industry (DEKRA)

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United States and Canada Related

• IVD Makers And Clinical Labs Wary Of LDT Rule Effects (MedTech Insight)
• FDA Advisory Committee Focuses On Improving Informed Consent For Patients Volunteering For Device Trials (MedTech Insight)
• FDA Updates Cybersecurity Page With New Publications For Cybersecurity Awareness Month (MedTech Insight)
• Opinion: The Fog at CDRH Is Lifting (a Bit) (MedTech Insight)
• FDA Drops Final Guidance On Safety Considerations For Neonatal Medical Products (MedTech Insight)
• Tarver In As FDA’s Device Center Director (MedTech Insight)
• Women’s Health Has Come A Long Way. But There’s Still A Long Way To Go (MedTech Insight)
• White paper highlights SBOM challenges for medical devices (RAPS)
• Tarver says clinical trial diversity action plans are a marketing opportunity (RAPS)
• Tarver named new CDRH director (RAPS)
• Shuren: Lawmakers should enable voluntary alternative pathway, international reliance (RAPS)
• Submission of single vs. separate marketing applications for combination products in the US (RAPS)
• FDA lists top 10 artificial intelligence regulatory concerns (Hogan Lovells)
• District of South Carolina Rejects Plaintiff’s “Better Late Than Never” Argument on Expert Reports (Drug & Device Law Blog)
• Challenging The Role of the Presumption Against Preemption in Fosamax (Drug & Device Law Blog)
• Another Blood and Tissue Statute Win (Drug & Device Law Blog)
• Alabama Supreme Court Applies AMLA Standards to Various Causes of Action (Drug & Device Law Blog)

Global Items / General Industry News

• The investigator’s toolkit: FRAM (HSSIB)
• SPC Charts — Are You Deploying this World-Class Tool? (AAMI)
• The role of medical physics experts in clinical trials: A guideline from the European Federation of Organisations for Medical Physics
• Safety principles for medical summarization using generative AI
• Quality evaluation of field safety notices of medical devices, across EU and non-EU countries
• Virtual Trials and the Future of Medical Imaging

Stay In the Know

• Visit the RQM+ Knowledge Center for upcoming and on-demand content
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• Follow RQM+ on LinkedIn for regular updates
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