RQM+ Weekly Watch #22

RQM+ Recap

RQM+ news, recent content, and upcoming events.

Presentation and Panel with FDA Now On Demand

[Now On Demand] Last Thursday RQM+ welcomed the FDA 's Michelle Tarver, MD, PhD , CDRH Acting Director and Deputy Center Director for Transformation, for Advancing Health Equity with IVDs & Medical Devices: Regulatory Expectations & Action Plans.

?? Download Michelle's slides and listen to the conversation ??

We encourage you to attend our future events live so you can ask your own questions.

Related Health Equity Technical Brief

Unbiased Outcomes: The Challenges of Equity in MedTech is our latest technical brief and a lengthy one at that (5,312 words, to be exact). Written by RQM+ Manager of Intelligence and Strategic Execution, Edward B. , it explores key regulatory expectations, strategies to eliminate biases, ways to ensure your innovations benefit all patient groups, and much more. We believe understanding and addressing health equity is not only the right thing to do, but also drives innovation forward.

?? Read the technical brief here ??

Clinical Trial Video Series Continues

RQM+ is continuing our educational video series on clinical trials. Clips cover three areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. All videos in the series will be able to be viewed on LinkedIn, our podcast (Apple, Spotify), and YouTube.

Videos thus far:

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

Upcoming In-Person Events and What's Next

See the complete list here. ??

What's Next ? RAPS Convergence 2024 - Long Beach, California, USA - 17-19 September

Visit RQM+ at booth 1017 and stop by the Discover Theater (booth 139) on 18 September (now one day earlier) to see our session, Leveraging Technology and Smart Templates to Optimize EU MDR Clinical Evaluation and Post-Market Surveillance Documentation presented by Jonathan Gimbel and Celeste Maksim, PhD, RAC .

?? View more information about the session and full agenda here ??

Europe

• The consolidated text versions of the MDR and IVDR have been updated to include the text from Regulation 2024/1860 (apart from Article 10a). It is worth noting the warning/disclaimer given around these versions of the regulations: “This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document”.
• EMA has launched a pilot programme for expert panels to support the development and assessment of orphan medical devices in the European Union (EU). The pilot programme offers free advice from the medical device expert panels to selected manufacturers and notified bodies on the orphan device status and the data needed for their clinical evaluation. While the pilot programme is currently scheduled to run until the end of 2025, the aim is to establish a long-term process for orphan device support.
• The first module (Actors) of Swissmedic's new database (swissdamed) is online. With the first release of the "Actors" module, economic actors can register online. Economic operators who had already registered with Swissmedic before swissdamed was made available should have been informed by Swissmedic about the next steps via the contact person provided.?
• The European Commission published a Q&A on the EU AI Act: Artificial Intelligence – Questions and Answers.
• The UK's Health Research Authority have published their project report (and Executive Summary) relating to their People-Centred Clinical Research project. ?

United States and Canada

• The FDA has updated the list of Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices, now totaling at least 950 AI/ML-enabled medical devices that have been authorized by the FDA.
• CDRH has developed a discussion paper, Discussion Paper: Health Equity For Medical Devices, and seeks input from the public on advancing health equity on the context of medical devices. In this discussion paper, CDRH describes factors and considerations that may be important for sponsors and other relevant parties as they develop medical device clinical studies and seeks feedback from the public. Specifically, the discussion paper request feedback on possible considerations that may help inform the design of a clinical study that adequately reflects the intended use population for a particular medical device.?
• The MDSAP Audit Approach (AU P0002) has been updated to version 009: MDSAP AU P0002 Audit Approach. The key changes from version 008 to 009 relate to the responsibilities of the Australian Sponsor and those of the legal manufacturer if based outside of Australia.

Rest of World

• TGA Disinfectants, sterilants and sanitary products updated guidance on how they are regulated in Australia.

Recalls, FSCAs, and Alerts

Class I Recall (United States)

• Ambulatory Infusion Pump Software Correction: Smiths Medical Issues Correction for CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pump Software due to Multiple Issues Related to Outdated Software
• Nerve Monitoring System Correction: Medtronic Issues Correction for NIM Vital Nerve Monitoring System due to the Potential for False Negative Response

FDA Safety Communications

• Risks with Exactech Joint Replacement Devices with Defective Packaging - FDA Safety Communication (Updated)

Other FSCAs / Safety Notices

• ANSM suspends Allurion gastric balloons (France)
• FSNs published in the UK: Field Safety Notices: 29 July to 2 August 2024

In the News

• Philips Says Outside Lab Screwed Up, Then Covered Up Testing Results Of Ventilator Foam
• Smiths Medical recalls infusion pumps over software issues
• Medtronic recalls nerve monitoring system linked to 10 injuries
• Philips sues independent lab, alleges ‘numerous egregious errors’ in CPAP foam tests

Warning Letters (United States)

• None this week.

Approvals and Clearances

• None this week.

In the News

• Big Health Gets Good Night Sleep With FDA Approval Of Insomnia Digital Therapeutic
• J&J To Launch Velys Spine Platform After Securing FDA Clearance
• Labcorp wins FDA OK for pan-solid tumor liquid biopsy
• Inspire wins FDA approval for obstructive sleep apnea neurostimulator therapy

Articles We Read

Note: MedTech Insight articles are labeled and most are behind a paywall, leading to a website page with only an Executive Summary. We include these because we recognize some of our readers subscribe to MedTech Insight and the links are helpful.

?Europe Related

• Medical device manufacturers: control your supply chain for MDR and IVDR requirements (Taylor Wessing)
• EMA pilot aims to advise on orphan device development (RAPS)
• EU Experts Vollebregt and Melvin Agree Over Nature Of Changes Needed To MDR (MedTech Insight)
• Time to deliver – BIVDA assesses the UK’s 2024-2029 AMR Action Plan (Pathology in practice)

?

United States Related

• New Consensus on the Sterilization of Single-Use Systems for Manufacturing (AAMI)
• CDRH issues discussion paper exploring health equity for medical devices (RAPS)
• FDA official: Chinese plastic syringe issues emblematic of larger manufacturing concerns (RAPS)
• FDA official clarifies misconceptions around RWE in premarket submissions (RAPS)
• Could Loper Bright Finally Do in FDA’s Rickety Off-Label Speech Ban? (Drug & Device Law Blog)
• News We’re Watching: Medtronic Recall; FDA Approves Injector For Opioid Overdose; EKO Teams Up With LSU Tigers For Heart Monitoring (MedTech Insight)
• Slow Burn: US FDA RMAT Designations Surge While Breakthrough Pace Softens (MedTech Insight)
• Digital Health Advisory Committee Announces Voting Members, Pool Of Industry Representatives (MedTech Insight)
• TCET Final Notice Leaves Much To Be Desired, Eyes Turn To Congress (MedTech Insight)
• FDA Looks To Achieve Greater Health Equity For Medical Device Access (MedTech Insight)
• ?(FDA Law Blog)
• Unpacking Averages: Is It Too Soon to Study the Postmarket Experience of AI-Driven Medical Devices? (Health Law Advisor Blog)
• FDA seeks feedback on health equity for medical devices
• Experts fear patient harm from FDA’s lab developed test rule

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