RQM+ Weekly Watch #28

RQM+ Recap

RQM+ news, recent content, and upcoming events.

3 Notified Bodies Join RQM+ Live! This Friday, 4 October

This Friday (not our usual Thursday!), three representatives from leading notified bodies – BSI , TÜV SÜD , and GMED – will explain how to engage in structured dialogue with notified bodies. They'll also answer questions! We hope to see you on Friday at 9am ET / 3pm CEST.

✔️ Learn more and join live 🗣️

Continuation of Clinical Trial Video Series

Videos 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

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! We hope to see you there.

Europe

• In their latest blog, the MHRA have provided an update on their plans for Med Tech regulatory change, including a consultation on what is being referred to as the ‘pre-market’ SI and another indication that the post-market SI will be laid by the end of 2024.
• The MHRA have also announced that their AI Airlock pilot is open to applications.
• SUKL in Slovakia have indicated that they have seen an enormous increase in notifications about medical devices and IVDs in relation to transitional arrangements, and are requesting that only mandatory notifications are submitted.
• MDCG 2021-4 application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 has been updated to REV 1. There have been edits made to Q1-Q6 and a new Q7 has been added.
• BSI have published a whitepaper on AI

United States and Canada

• The FDA have updated their guidance on the Safety and Performance Based Pathway (expansion of the concept of the Abbreviated 510(k) pathway for certain, well-understood device types). This included the publication of the following final guidance documents:
• — Air Powered Dental Handpieces and Air Motors - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff
• — Dental Cements - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff
• — Dental Ceramics - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff
• — Dental Impression Materials - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff
• — *Need to refresh your memory on this pathway? The recording and slides from the 2020 FDA webinar are still available.
• The FDA have published a final version of their guidance “Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment: Guidance for Industry and Food and Drug Administration Staff”
• The recording and slides from the recent FDA webinar “Labeling Requirements for In Vitro Diagnostic Products (IVD), Including LDTs, Under 21 CFR 809.10(b)” are now available.
• The FDA are proposing a reclassification of qualitative hepatitis B virus (HBV) antigen assays, qualitative HBV antibody assays and quantitative assays that detect anti-HBs (antibodies to HBV surface antigen (HBsAg)), and quantitative HBV nucleic acid-based assays, from class III devices, to class II (general controls and special controls), that would be subject to premarket notification. The FDA is also proposing three new device classification regulations along with the special controls that they believe are necessary to provide a reasonable assurance of safety and effectiveness for each device. The proposal is open for comments until 25th November 2024.

Rest of World

• RAPS have published their Global Compensation and Scope of Practice Report for the Regulatory Profession.
• The Federal Court of Australia has ordered Medtronic Australasia Pty Ltd (Medtronic) to pay $22 million in penalties for unlawfully supplying 16,267 units of the Infuse Bone Graft Kit between 1 September 2015 and 31 January 2020. 

Recalls, FSCAs, and Alerts

Class I Recall (United States)

• Class I Recall: Compounding Device Inlet Correction: Baxter Healthcare Corporation Updates Use Instructions for Exactamix Automated Compounding Device Inlets due to Risk for Particulate Matter in Device Components

FDA Safety Communications

• None this week.

Other FSCAs / Safety Notices

• FSNs published in the UK: Field Safety Notices: 23 to 27 September 2024

In the News

• Recalled heart devices had limited clinical testing, study finds
• FDA boosts 3 recalls of Smiths Medical ventilators, trach tubes

Warning Letters (United States)

• None this week.

Approvals, Clearances, and Classifications

Consumer Information:  Altius Direct Electrical Nerve Stimulation System - P230020 (Neuros Medical, Inc.)

De Novo Decision Summaries Updated:

• DEN230019 - AXIOS Stent and Electrocautery-Enhanced Delivery System
• DEN230002 - DuraGraft Vascular Conduit Solution
• DEN220087 - Edison System
• DEN230021 - ensoETM™
• DEN220078 - Eroxon

Articles We Read

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

Europe Related

• UK MHRA Keeps Up Momentum For Change With ‘Pre-Market SI’ Devices Consultation (MedTech Insight)
• UK Medtechs Rue Low Cap Of Rules-Based Innovation Adoption Plan, Note AI Airlock Progress (MedTech Insight)
• Urgent Action Needed To Address Deficiencies In EU's IVD Regulation – As Well As MDR (MedTech Insight)
• Euro Roundup: Commission posts guide to validity of studies for joint clinical assessments (RAPS)
• How to make software medical device requirements testable (Scarlet)

United States Related

• Pilot To Program: FDA Issues Accreditation Scheme For Conformity Assessment Draft Guidances (MedTech Insight)
• Convergence: CDRH on track to meet its FY 2023 MDUFA V performance goals, says Tarver (RAPS)
• 5 highlights from RAPS Convergence 2024 (RAPS)
• FDA releases three post-pilot ASCA draft guidances (RAPS)
• AAMI, CTA to Collaborate on AI Standards (AAMI)
• Innovation to Market — Insights from Developing a Class 1 Med Device (AAMI)
• FDA: New Premarket Med Device Guidance for ASCA Program (AAMI)
• Lawmakers call for investigation of former FDA device director (MedTech Dive)
• FDA proposes reclassifying hepatitis B assays (MedTech Dive)
• FDA names new head of medical device evaluation and quality (MedTech Dive)
• 4 steps to minimize the threat of legacy medical devices (MedTech Dive)
• FDA posts draft guidance on biocompatibility testing of devices (MedTech Dive)
• Litigation Funding Discovery from Secondary Payor Troll (Drug & Device Law Blog)
• Cutting Through the FDA Alternative Summary Reporting Fog (Drug & Device Law Blog)
• DNY Dismisses Glucose Monitoring Device False Claims Act Case (Drug & Device Law Blog)
• Knock, Knock. Who’s There? Breakthrough Device. Breakthrough Device Who? Breakthrough Device That Can’t Get to Market (FDA Law Blog)

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