RQM+ Weekly Watch #31

RQM+ Recap

RQM+ news, recent content, and upcoming events.

?? Technical Brief: Structured Dialogue: A Key to Efficient Regulatory Compliance in the EU

Fresh off of our panel discussion with notified body representatives from 英国标准协会 , TüV SüD , and GMED on structured dialogue comes a compact snapshot from Jaishankar Kutty, Ph.D. , Vice President of Global Regulatory Affairs at RQM+. Read the new brief in 4-5 minutes and consider checking out the on-demand presentation and panel when you have more time.

?? Read the Technical Brief Now ??

Major Updates In Our Clinical Trial Video Series

The videos in this series cover clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. All videos can be viewed on LinkedIn, (links below), Apple, Spotify, and YouTube.

1. Introducing Our Educational Video Series on Clinical Trials
2. Strategy for First-in-Human Studies (1/2)
3. Strategy for First-in-Human Studies (2/2)
4. Tactics for First-in-Human Studies
5. Strategy for Global Pivotal Studies
6. Tactics for Global Pivotal Studies
7. Would you like to get reimbursed?
8. Key Aspects of Medical Device Trial Design (1/2)
9. Key Aspects of Medical Device Trial Design (2/2)
10. Strategy & Tactics for Combination Device Clinical Trials
11. Navigating Regulatory Landmines for Combination Products
12. Site Selection In Clinical Trials
13. Site Monitoring In Clinical Trials
14. Tactical Considerations for IVD Clinical Trials
15. Secrets of Site Selection and Monitoring for IVD Studies (Part 1/2)
16. Secrets of Site Selection and Monitoring for IVD Studies (Part 2/2)
17. Data Management In Clinical Trials (Setup Phase)
18. Data Management In Clinical Trials (Maintenance/Closeout)
19. How a CRO Helps with Data Management In Clinical Trials
20. Effective and Efficient Safety Management In Clinical Trials
21. Best Practices In AE Reporting In Clinical Trials
22. What makes a successful regulatory submission? (Part 1/3)
23. What makes a successful regulatory submission? (Part 2/3)
24. What makes a successful regulatory submission? (Part 3/3)

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 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 2021-5 to revision 1. MDCG 2021-25 rev.1 Application of MDR requirements to "legacy devices" and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC
• The European Commission published an update on the status of conformity assessment bodies going through designated for the MDR & IVDR. Currently there are 5 more Notified Bodies for MDR and 3 more for IVDR that are at the CAPA review stage with the Joint Assessment Team (JAT).?
• On the back of discussions in the European Parliament last week, MedTech Europe sent an Open letter to Stella Kyriakides on the urgent need for action on the medical technology regulations.
• And the Heads of Medicines Agencies sent a letter to the Director General for Health and Food Safety (DG SANTE) on the same topic.
• Those discussions in the European Parliament also progressed with 8 motions for resolutions being lodged ahead of the next meeting.

United States

• The Combination Products Coalition sent a letter to the FDA regarding the draft guidance ‘Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products’

Rest of World

The IMDRF published the outcome statement from their 26th Management Committee meeting in Seattle (September 2024). Points to note:

— The Saudi Food and Drug Authority (SFDA) are now an official observer to the IMDRF;

— The MC agreed to:

• — Approve the final document titled “Common Data Set for Adverse Event Data Exchange Between IMDRF Regulators” (IMDRF AET WG/N85) from the Adverse Event Terminology (AET) Working Group.?
• — Approve the draft document titled “Consideration for the selection of IMDRF Adverse Event Terminology codes and terms” for a 60-day public consultation. (Closing date 9 Dec 2024). The IMDRF Adverse Event Terminology Working Group and the MHRA will host a virtual webinar on Thursday 24th?October 2024 (3-4pm BST) to discuss this document. Refer to?IMDRF Events?for further information and how to register.
• — To Approve the revised New Work Item Proposal (NWIP) of the Artificial Intelligence/Machine Learning-enabled (AI/ML) Working Group for a document outlining a technical framework for AI lifecycle management.?
• — Approve the NWIP of the Software as a Medical Device (SaMD) Working Group to develop a document on the essential principles and content of Predetermined Change Control Plans (PCCPs).

• — There is currently an Online Survey for Sponsors of Medical Device Clinical Investigations open for input.

Recalls, FSCAs and Alerts

Class I Recall (United States)

• Vascular Embolization Device Correction: Boston Scientific Updates Use Instructions for Obsidio Conformable Embolic for Increased Ischemia Risk When Used for GI Bleeding
• Insulin Pump Recall: Medtronic Notifies Users of MiniMed 600 and 700 Series Pumps of Risk of Shorter than Expected Battery Life

FDA Safety Communications

• None this week.

Other FSCAs / Safety Notices

• The HPRA advised that a number of Defibtech automated external defibrillator (AED) pads supplied to the Irish market have been affixed with unauthorised labels. (Ireland)
• Medical devices affected by 3G network closure in October 2024 (Australia)
• FSNs published in the UK: Field Safety Notices: 18 October 2024

In the News

• FDA labels Cue’s recall of COVID tests as Class II, revokes EUAs

Warning Letters (United States)

• None this week.

Approvals, Clearances, and Classifications

De Novo Classification Order: DEN240029 - Healgen Rapid Check COVID-19/flu A&B Antigen Test

De Novo Decision Summaries (Updated):

• DEN200076 - ORi
• DEN210058 - ELEOSx? Limb Salvage System
• DEN220015 - Orthobond Mariner Pedicle Screw System
• DEN220073 - Revi System
• DEN230008 - DermaSensor
• DEN230035 - DentalMonitoring
• DEN230043 - Notal Vision Home Optical Coherence Tomography (OCT) System
• DEN230081 - Hearing Aid Feature
• DEN240013 - MagDI System

In the news:

• Novocure wins FDA approval for electric field device in lung cancer
• CMR Surgical gets FDA de novo nod for Versius robot

Articles We Read

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

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Europe Related

• Get your AI Act together: The impact of the EU’s AI regulation on medical device market access (Scarlet)
• ‘Onerous’ EU rules will limit patient access to new devices, medtech chief warns
• Euro Roundup: MEP calls medtech rules a ‘bureaucratic monster’ as calls for change intensify (RAPS)
• MHRA to launch consultation on device international reliance plan by year’s end (RAPS)
• Euro Roundup: MHRA outlines steps to accelerate access to medical products (RAPS)
• Germany’s Hospital And Reimbursement Reform Battles Into The Final Straight (MedTech Insight)
• EU Industry Calls On Commission To Introduce MDR/IVDR Bridging Measures (MedTech Insight)
• Stop Going Round In Circles: UK Medtechs Told How To Be Sustainable (MedTech Insight)
• NoBoCap: Notified Bodies Want To Deliver More Transparency And Predictability (MedTech Insight)
• NoBoCap: Is Structured Dialogue The Key to Unlocking Medtech Innovation? (MedTech Insight)
• Medtechs Dig Deep For UK System Positives But Take Issue With MHRA Fees Hike (MedTech Insight)
• NoBoCap: Navigating The EU Regulatory Landscape For MedTech Innovation (MedTech Insight)
• Medtech Europe calls for urgent reform of MDR and IVDR
• Legacy medical devices keep regulators up at night

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United States and Canada Related

• CDRH officials say pre-submission meetings can improve odds for de novo requests ?(RAPS)
• FDA officials outline need for oversight of AI in healthcare, biomedicine (RAPS)
• Health Canada digital health head says AI/ML guidance imminent (RAPS)
• Risk and data availability key to regulating health equity in device development (RAPS)
• Passing The Torch: Tarver Addresses Audience At FDA Town Hall, Recognizes Shuren’s Accomplishments (MedTech Insight)
• Balancing Diversity and Effectiveness: Industry Feedback on FDA’s DAP Guidance (MedTech Insight)
• Lawsuits To Stop FDA From Overseeing LDTs Could Create Chaos, Panelist Says (MedTech Insight)
• Picture This: FDA Pilot Shares Device Trial Participation Snapshots (MedTech Insight)
• Animal Testing Alternatives Need Central Office At US FDA, Science Board - Clone (MedTech Insight)
• Cybersecurity And LDT Enforcement Top FDA’s Guidance Priorities for 2025 (MedTech Insight)
• Using TwIqbal To Require Plaintiffs To Identify Claimed Warning Inadequacy (Drug & Device Law Blog)
• Reining in “Any and All” Discovery (Drug & Device Law Blog)
• We Applaud The Preemption Analysis And Outcome In Mack v. CooperSurgical, Inc. (2024) While Bemoaning Those In Mack v. CooperSurgical, Inc. (2023) (Drug & Device Law Blog)
• Medical Device Claims Preempted in Ohio (Drug & Device Law Blog)
• Tarver, acting CDRH director, sets tone for future of the device center (MedTech Dive)
• FDA prioritizes guidance on lab developed tests in 2025 plan (MedTech Dive)
• FDA, Health Canada give sneak peek into future AI regs ?(MedTech Dive)
• Health officials outline industry role in AI oversight in JAMA article ?(MedTech Dive)

Global / General Industry News

• Ethics and Innovation in Medical AI: A Conversation with Dr. Paul Campbell

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