RQM+ Weekly Watch #29

RQM+ Recap

RQM+ news, recent content, and upcoming events.

RQM+ Live! with BSI, TüV SüD, and GMED Now On Demand

[Now On Demand] Last week RQM+ was joined by representatives from leading notified bodies BSI, TüV SüD, and GMED to discuss structured dialogue. From live attendees:

?? I was very impressed with the caliber of the speakers and their engagement with the questions. Fantastic webinar, thank you.

?? The guests were experts and that is why the webinar was useful.

?? New to the world of NB and found this session hugely useful and informative. Thank you!

?? Love the format, platform, and amount of time "setting up the discussion" with the audience. Very smooth.

?? This has been one of the best RQM+ sessions I have attended. Super awesome information.

?? Download their presentation slides and watch the recording here ??

New Technical Brief on Point of Care Tests

Read our newest technical brief written by Director of IVD Global Regulatory Affairs, Margot Borgel, Ph.D. . The brief compares the regulatory requirements for Point of Care Tests (POCTs) in the U.S. and EU, highlighting the U.S. CLIA's complexity-based system versus the EU IVDR's focus on device design and performance, and stresses the need for careful planning to navigate these differences for market access.

?? Read the Technical Brief Here ??

Upcoming In-Person Events and What's Next

See the complete list here. ??

Featured Event ? The MedTech Conference ( AdvaMed ) - Toronto, Canada - 15-17 October

Visit us at booth 631 across from the food court to meet our team! Here are the full details of where you can find us (LinkedIn link) and we hope to see you there!

Europe

• As of 1st October 2024, the European Reference Laboratories (EURLs) for Class D IVDs are now in operation. Here is Team-NB's press release on the subject.
• The recording of the EMA's Information session on the pilot for expert panels' advice for orphan medical devices (23rd September 2024) is now available to watch back on-demand.
• The HPRA are seeking comments on their proposal to increase their 2025 fees by 5%.

United States and Canada

• The FDA have updated CDRH’s Customer Collaboration Portal (CDRH Portal) to:
• The FDA's Total Product Life Cycle Advisory Program (TAP) Pilot was expanded to now include medical devices reviewed by the Division of Ophthalmic Devices (DHT1A) and the Office of Radiological Health (OHT8). From 1st January 2025, the TAP Pilot will expand to include the Office of Orthopedic Devices (OHT6). Currently, the TAP Pilot is accepting enrollment requests for Breakthrough Designated devices reviewed by the:

Rest of World

• The WHO has listed the first mpox in vitro diagnostic (IVD) under its Emergency Use Listing (EUL) procedure. The approval for emergency use of?the Alinity m MPXV assay, manufactured by Abbott Molecular Inc., will be pivotal in expanding diagnostic capacity in countries facing mpox outbreaks, where the need for quick and accurate testing has risen sharply. Early diagnosis of mpox enables timely treatment and care, and control of the virus. Limited testing capacity and delays in confirming mpox cases persist in Africa, contributing to the continued spread of the virus. In 2024, over 30 000 suspected cases have been reported across the region, with the highest numbers in the Democratic Republic of the Congo, Burundi, and Nigeria. In the Democratic Republic of the Congo, only 37% of suspected cases have been tested this year.

Recalls, FSCAs, and Alerts

Class I recall (US)

• IPV Therapy Device Correction: Sentec/Percussionaire Updates Use Instructions for Phasitron 5 In-Line Valve to Prevent Accidental Misuse of Expiratory Port Plug
• Infusion Pump Software Correction: Fresenius Kabi USA, LLC, Issues Correction for Ivenix Infusion System Large Volume Pump (LVP) Software due to Multiple Anomalies that May Cause Delay or Underdosage of Therapy
• Ventilator Software Correction: Philips Respironics Issues Mandatory Software Correction and Updates Use Instructions for Trilogy Evo, EV300, EvoO2, and Evo Universal to Address Multiple Issues that May Impact Ventilation
• Ventilator Correction: Smiths Medical Issues Correction for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal Volume Knob Movement

FDA Safety Communications:

• None this week.

Other FSCAs / Safety Notices?

• Australia: Counterfeit Ozempic pens detected and adverse event reported
• UK: Philips Respironics BiPAP A series ventilators: alarm malfunction and risk of therapy interruptions in ventilators not intended for life-support, DSI/2024/006. Updated: Philips Respironics have now published a further Field Safety Notice (FSN) on actions they will be taking to address this issue. This includes updates to the instructions for use (IFU) for the BiPAP A40 and A40 Pro devices, and financial/replacement options for affected users.?
• FSNs published in the UK: Field Safety Notices: 30 September to 4 October 2024

In the News

• Philips issues fix for ventilator problems linked to 9 injuries, 1 death

Warning Letters (United States)

• None.

In the news:

• FDA boosts Philips recall of hospital, home ventilator software.

Approvals, Clearances, and Classifications

De Novo Classification Order: DEN230067 - Chronos?

De Novo Decision Summaries (Updated)

• DEN220040 - Fibresolve
• DEN220026 - VasQ
• DEN230020 - BioTraceIO Lite
• DEN210056 - ProciseDx Inc.
• DEN230050 - Body Temperature Software (BTS)
• DEN220090 - EasySep? Human Bone Marrow CD138 Positive Selection Kit
• DEN230012 - Ruthless Spine RJB
• DEN220023 - Procise ADL

In the news:

• FDA approves Exact Sciences’ next-gen Cologuard Plus home test
• Siemens Healthineers scores FDA nod for 5-second, 3D mammography
• FDA clears Pi-Cardia's leaflet splitter for valve-in-valve TAVR
• GE HealthCare's PET tracer for heart disease nets FDA approval
• Remedee nabs EU approval for fibromyalgia wristband therapy
• Elucid wins FDA 510(k) nod for heart plaque image analysis software
• FDA authorizes Pi-Cardia’s valve-in-valve TAVR device
• Siemens Healthineers wins FDA approval for 3D mammography system
• GE Healthcare gets FDA nod for new PET imaging agent
• Establishment Labs wins FDA approval for Motiva breast implants

Articles We Read

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

?

Europe Related

• MHRA Promises UK Devices Regulation Will Enter ‘New Era Of Evolution’ (MedTech Insight)
• EURLs Go Live: A New Era For High-Risk IVDs (MedTech Insight)
• UK’s ISRCTN Registry Makes It Easier To Track Clinical Trial Transparency (MedTech Insight)
• EU Regulatory Round-Up, September 2024: Change Is In The Air (MedTech Insight)
• EMA adopts reflection paper on AI/ML in drug development (RAPS)

?

United States Related

• Toward trustworthy medical device in silico clinical trials: a hierarchical framework for establishing credibility and strategies for overcoming key challenges (Frontiers in medicine)
• COVID-19 Test Fraud Cases Reach Resolution (MedTech Insight)
• Modernizing Medical Device Design Control: From Waterfalls to a New Landscape (MedTech Insight)
• X-ray Regulations Detailed In New FDA Guidance (MedTech Insight)
• FDA Opens Performance Pathway To Four Dental Device Types (MedTech Insight)
• Device Shortages A Matter Of National Security, Califf Says (MedTech Insight)
• Stakeholders warn of potential burdens in FDA’s drug delivery guidance (RAPS)
• Diversity action plans: Stakeholders seek clarity on demographic data, enrollment, and global trials (RAPS)
• FDA finalizes Q&A guidance on electronic records in clinical trials (RAPS)
• FDA pulls the trigger on major agency reorganization (RAPS)
• Califf calls for mandatory reporting of device shortages (RAPS)
• Advancing Pediatric Medical Countermeasures Through the Newly BARDA-Funded Accelerator, SPARK for Innovations in Pediatrics (AAMI)
• As New FDA Draft Guidance Broadens Scope of PCCPs, AI Remains a Priority (AAMI)
• Independent lab fires back after Philips sues over testing results (MedTech Dive)
• Using TwIqbal To Enforce Warning Causation in Learned Intermediary Cases (Drug & Device Law Blog)
• E.D.N.Y. Finds Fraudulent Joinder of Sales Representative with No Connection to Plaintiff (Drug & Device Law Blog)
• Group Pleading, No Causation Leave Plaintiff Blue In Kentucky (Drug & Device Law Blog)
• Unpacking Averages: Assessing FDA’s Postmarket Surveillance Under Section 522?
• Global Hospital Budgets: A New Trend? (Health Law Advisor Blog)
• As the Window for Comments Closes on ONC/ASTP’s HTI-2 Proposed Rule: What’s in HTI-2 and What Does It Mean for You? (Health Law Advisor Blog)
• Indeterminate Change: FDA Releases Draft Guidance on Predetermined Change Control Plans for Medical Devices (FDA Law Blog)

General Industry News

• Prostate cancer study finds equal gains in IMRT vs. proton beam
• Post-Market Surveillance and Vigilance: Requirements for MDSAP (DQS)

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