RQM+ Weekly Watch #25

RQM+ Recap

RQM+ news, recent content, and upcoming events.

?? [This Week] MDR/IVDR Amendments Panel with Special Guests

Secure your spot for this Thursday's panel, which will explore the implications for manufacturers due to the MDR and IVDR amendments. Our panelists – including guests Heike Moehlig-Zuttermeister of TüV SüD , Erik Vollebregt of Axon Lawyers , and Donielle Johnson – will discuss strategies for supply interruption compliance and the impacts on MedTech.

?? Learn more and join the panel discussion here ?

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)

?? RQM+ at RAPS Convergence In Long Beach, CA Next Week

?? Four ways to find us at the Regulatory Affairs Professionals Society (RAPS) Convergence

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16-17 Sept. | 8:30 AM – 4:00 PM PDT

RQM+ VP of MedTech Innovations, Allison Komiyama, PhD, RAC , is one of the instructors. She joins Mark DuVal, J.D. FRAPS , Lisa Pritchard , Kathy Herzog , Dongbo Wang , and FDA /CDRH Deputy Ombudsman, Ken Skodacek.

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Wednesday, 18 Sept. |?8:15 AM – 9:00 AM PDT

Allison Komiyama, PhD, RAC is a panelist, along with Cheryl Coon , Karl-Heinz Huemer , and Justin West, MD . Jo?o Duarte will moderate.

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Wednesday, 18 Sept. | 12:25 PM – 12:50 PM PDT

RQM+ Vice President of Technical, Jonathan Gimbel , will present, and be joined by Fern.ai Product Manager, Sara Contu , MSc.

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If you're attending, please stop by!?We can't wait to meet and catch up with attendees in person. You can enter for a chance to win a ?, too.

Europe

• The European Commission published some Frequently Asked Questions about the Data Act. This supplements the existing Data Act Explained page.
• ABHI published their Summer 2024 regulatory round up.

United States and Canada

• The FDA published draft guidance on Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle. This draft guidance is intended to communicate when and what methods could be used to collect and submit patient preference information (PPI) across the total product life cycle (TPLC). According to the FDA , "This will include helping explain when PPI may be helpful, and in what context. Without this re-issuance, sponsors and other patient preference study developers will not be aware of updated methodologies and considerations, which could result in costly studies that may not be appropriate to inform benefit-risk decision making".
• The FDA have published their most recent presentation on GUDID (Global Unique Device Identification Database) trends, dated August 2024. The GUDID contains records submitted by medical device labelers in accordance with the UDI Rule. The presentation indicates the geographical spread of the companies registered in GUDID, the most frequent therapy areas (e.g. implantable devices represent ~31%) and classifications (e.g. Class II ~60% of the registrations).
• The FDA updated their list of medical devices that incorporate Augmented Reality and Virtual Reality (AR/VR). With this update, the FDA believe that they have authorized 69 medical devices that incorporate Augment Reality (AR) and Virtual Reality (VR).?
• In classification news, the FDA have published some recent classification decisions: FDA has classified the endoscopic pancreatic debridement device as class II (special controls); FDA has classified the blood collection device for cell-free nucleic acids as class II (special controls); FDA has classified the hemodialyzer with expanded solute removal profile as class II (special controls); FDA has classified the adjunctive open loop fluid therapy recommender as class II (special controls); FDA has classified the radiofrequency toothbrush as class II (special controls); FDA has classified the heparin and direct oral factor Xa inhibitor drug test system as class II (special controls); FDA has classified the hydrophilic re-coating solution as class II (special controls)

Rest of World

• The IMDRF have published their Implementation Report (IMDRF/MC/N84 FINAL:2024) summarizing the national/regional implementation of key IMDRF guidance documents.
• The Council for International Organizations of Medical Sciences (CIOMS) released the 75th Anniversary Edition of the CIOMS cumulative glossary, with a focus on pharmacovigilance. This highly popular glossary compiles all the definitions from across the CIOMS Working Group reports on pharmacovigilance and related topics, reflecting almost four decades of CIOMS strategic influence in the field.

Recalls, FSCAs & Alerts

Class I Recall (United States)

• Laryngoscope Recall: Medtronic Removes Certain McGrath MAC Video Laryngoscopes, Updates Use Instructions for Others due to Increased Risk for Battery Overheat and Explosion
• Continuous Glucose Monitoring (CGM) Sensor Recall: Abbott Diabetes Care Inc Issues Recall for Certain FreeStyle Libre 3 Sensors due to Risk for Inaccurate High Glucose Readings
• Ventilator Correction: Breas Medical Updates Use Instructions for Vivo 45 LS due to Potential Elevated Formaldehyde Levels in Newly Manufactured Ventilators
• Lung Therapy Component Recall: Baxter Healthcare Corporation Recalls Certain Volara System Single-Patient Use Circuits and Blue Ventilator Adapter Assemblies Due to Disconnection Risk That May Prevent Proper Ventilation

FDA Safety Communications

• Smiths Medical Issues Urgent Medical Device Notification Informing Customers of a Potential Issue with Certain Bivona? Tracheostomy Tubes

Other FSCAs / Safety Notices

• CPT Hip System Femoral Stem 12/14 Neck Taper: Increased Risk of Postoperative Periprosthetic Femoral Fracture, DSI/2024/007 (UK)
• FSNs published in the UK: Field Safety Notices: 2 to 6 September 2024

In the News

• FDA boosts Medtronic scope recall over battery explosion risk

Warning Letters (United States)

None this week.

In the News

• Warning Letters – August 2024 (MedTech Insight)
• FDA cracks down on ozone cleaners for CPAP machines
• FDA sends warning letters to eye implant, bone matrix manufacturers
• Four companies warned for selling unauthorized CPAP cleaners

Approvals, Clearances, and Classifications

Nothing to report this week.

In the News

• Bleep Bloop Blood: Vitestro’s Automated Blood-Drawing Robot Cleared For EU Market
• FDA approves re-expandable stent that grows along with infants

Articles We Read

Note: We're including some articles that are behind a paywall (MedTech Insight) and will clearly note when that's the case. We recognize some readers subscribe and links are helpful.

Europe Related

• Device Post-Market Work In Scope Under MHRA’s 16% Cost Coverage Fee Hike (MedTech Insight)
• Video: How To Efficiently Patch A Medtech Regulatory System ‘Set Up To Fail’ (MedTech Insight)
• EU Regulatory Roundup, August 2024: Need For MDR Changes Continues To Absorb Sector (MedTech Insight)
• A vision for Europe’s medtech future: Safeguarding Europe’s access to medtech and innovation (MedTech Europe)
• European heart group recommends renal denervation for some patients (MedTech Dive)
• Euro Roundup: MHRA seeks feedback on fee changes intended to ensure ongoing cost recovery

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United States Related

• FDA has massive backlog of factory inspections as staffers leave for private sector jobs
• FDA Guidance Encourages Companies To Include Patient Preferences In Submissions (MedTech Insight)
• FDA Announces Four New Device Classifications (MedTech Insight)
• Unpacking Averages: How Old Are Medical Devices on the US Market? (Health Law Advisor blog)
• Debunking Another Stunningly Wrong MDL Expansion of Liability (Drug & Device Law Blog)
• There Is No Substitute: Arizona Law Does Not Permit FDA Warnings To Stand In For Expert Opinion (Drug & Device Law Blog)
• Where Have All the De Novo Summaries Gone: An Update (FDA Law Blog)
• Syringes: Current Quality & Supply Chain Concerns Follow a 2,000-Year History (AAMI)
• Troubleshooting HTM’s Supply Chain Issues (AAMI)
• FDA updates patient preference guidance to span the product life cycle

General Industry News

• The importance of a universal definition for medical devices (GMDN Agency)
• Diagnostic errors are common. Here are 4 ways to prevent them. (MedTech Dive)
• AI still the most exciting emerging technology for healthcare: survey (MedTech Dive)

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