RQM+ Weekly Watch #21

RQM+ Recap

RQM+ news, recent content, and upcoming events.

Upcoming Online Event with FDA

[Upcoming] 8 August presentation and panel – RQM+ welcomes 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.

??? Participate in the discussion and sign up ?

If you can't make the event live, we encourage you to register anyway to be sent the presentation slides, recording, and timestamps with topics covered.

New Technical Brief

Unbiased Outcomes: The Challenges of Equity in MedTech is our latest technical brief and a comprehensive one at that (5,312 words, to be exact). Written by RQM+ Manager of Intelligence and Strategic Execution, Edward B. , it explores key regulatory expectation, strategies to eliminate biases, ways to ensure your innovations benefit all patient groups, and 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 ??

Video and Audio Resources

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. ??

Event Highlight ? Horizon 2024 - Copenhagen, Denmark - 20-21 November

RQM+ Senior VP of Scientific Affairs, Amie Smirthwaite, PhD, FRAPS , will be chairing the Clinical Investigations, Regulation and Market Access for Medical Devices and IVDs event in Copenhagen in November. Early registration ends 15 August.

?? View the program here ??

Europe

• The EU's AI regulation (formerly known as the AI Act, may still continue to be called the AI Act) came into force last week: REGULATION (EU) 2024/1689...of 13 June 2024 laying down harmonised rules on artificial intelligence and amending...(EU) 2020/1828 (Artificial Intelligence Act).
• The European Commission is currently considering allowing the use of Electronic Instructions for Use (eIFU) for all professional use devices (i.e. devices that are used by healthcare professionals). They have opened a survey to seek contributions and feedback from Healthcare professionals and or other persons working in or employed by a healthcare institution in the European Union. Currently, requirements relating to eIFU are covered by Commission Implementing Regulation (EU) 2021/2226. This survey arrives after several trade associations have been pushing for the expansion of what devices are permitted to be supplied with eIFU (here and here).
• Commission Implementing Decision (EU) 2024/2120 of 30 July 2024 was published, renewing the designation of issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices. The designation of the issuing entities listed in the Annex to Implementing Decision (EU) 2019/939 is renewed for a period of five years from 27 June 2024 until 27 June 2029.
• The MHRA updated their guidance for how to register medical devices to reflect changes to the registration system, with specific updates to the two reference guides: 'Account Management Reference Guide' & ‘Device Registration Reference Guide’.
• The MHRA have also added information regarding the use of Regulatory advice meetings as part of planning for clinical investigations in the UK.

United States and Canada

• The FDA announced their User Fees for FY 2025 (October 1, 2024, through September 30, 2025). The Annual Establishment Registration Fee is $9,280. This applies to all establishments. There are no waivers or reductions for small establishments, businesses, or groups in FY 2025. Other fees for Fiscal Year 2025 are listed here.
• CDRH have updated their information pages regarding the reprocessing of single-use medical devices: Information for Health care Facilities and Frequently Asked Questions.

Rest of World

• RAPS spoke with various speakers scheduled for RAPS Convergence 2024 and asked for their thoughts on the biggest regulatory affairs trends in 2024. Here's what they had to say, including RQM+'s Allison Komiyama, PhD, RAC : What are the biggest regulatory affairs trends in 2024?

Recalls, FSCAs & Alerts

Class I Recall (US)

• None this week

FDA Safety Communications

• Safe Use of Megadyne Mega 2000 and Mega Soft Patient Return Electrodes – Letter to Health Care Providers

Other FSCAs / Safety Notices

• FSNs published in the UK: Field Safety Notices: 22 to 26 July 2024; Field Safety Notices: 29 July to 2 August 2024

In the News

• FDA, Health Canada team up to raise awareness of J&J’s Megadyne recall
• Abbott recalls Freestyle Libre 3 sensors due to incorrect glucose readings

Warning Letters (United States)

• AMCO International Manufacturing & Design, Inc. MARCS-CMS 681557 — June 25, 2024 [Adulterated product due to no PMA]
• Also in the news: FDA sends warning letter to defibrillator battery manufacturer

Approvals and Clearances

• MagDI System - DEN240013 (GT Metabolic Solution, Inc.)
• Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit - DEN230092 (DiaSorin Molecular LLC)
• Terragene Bionova Photon Biological Indicator (BT225);Terragene Bionova Photon Auto-Reader Incubator (BPH) - DEN220042 (Terragene SA)
• In situ polymerizing peripheral nerve cap - DEN230061 (Tulavi Therapeutics)
• Also in the news: Guardant wins FDA approval for colon cancer blood test

Articles We Read

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

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Europe Related

• EU Regulatory Roundup, July 2024: Medtech Ponders AI Act As Debate Over MDR Fix Continues (MedTech Insight)
• Orphan Devices Pilot Program Tackles Parliament’s Proposal Head On? (MedTech Insight)
• Pilot Phase For UK MHRA’s AI Airlock To Get Underway Post-Summer? (MedTech Insight)
• EU Authorities Call For Thorough Analysis To Avoid Medtech Regulation Review Errors? (MedTech Insight)
• Two High-Profile Members Of Newly Elected European Parliament Have Valuable Medtech Expertise (MedTech Insight)

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United States Related

• Will the End of Chevron Impact How We Use Standards? (AAMI)
• FDA unveils FY 2025 user fee rates (RAPS)
• Pennsylvania Federal Court Holds Online Marketplace Has No Duty to Inspect Goods (Drug & Device Law Blog)
• A New Destination For Litigation Tourism? (Drug & Device Law Blog)
• Hip, Hip … Meh? N.D. Cal. Issues Mixed Bag of Rulings on Hip Implant Claim (Drug & Device Law Blog)
• In Important First, Claims Implicating Class II Medical Device that Received De Novo Classification Held Expressly Preempted (Drug & Device Law Blog)
• Defense Verdict Upheld on Appeal in Missouri Bair Hugger Trial? (Drug & Device Law Blog)
• NEMA Voices Support For China Tariffs Delay? (MedTech Insight)
• Device User Fees Up 12% For FY 2025? (MedTech Insight)
• Could SCOTUS Chevron Reversal Reverse FDA’s Final Rule On LDTs?? (MedTech Insight)
• The Case For Quality: The Value Of The Voluntary Improvement Program (MedTech Insight)
• DHCoE AI Lifecycle Management Plan To Serve As ‘Playbook’ For Standards (MedTech Insight)
• Wound Products, Antimicrobial Resistance, and Commercial Speech: FDA’s Solution in Search of a Problem (FDA Law Blog)
• Experts fear patient harm from FDA’s lab developed test rule
• Patient shares a day in the life with diabetes at FDA’s first Home Health Hub meeting
• FDA officials outline benefits of AI lifecycle management
• AI’s expert-level image analysis can be built on flawed rationales: study

General Industry News

• Philips’ orders and sales held back by China’s anti-corruption push

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