RQM+ Weekly Watch #18

RQM+ Recap

RQM+ news, content recently published, and upcoming online events.

Technical Brief and White Paper

• [White Paper Teaser / Technical Brief] The German DiGA Idea: Revolutionizing Health Care with Digital Health Applications

[New White Paper] Written by Senior Medical Writer Cordula Stover, MD PhD , this new whitepaper explores how the DiGA concept, originally pioneered in Germany, is revolutionizing health care by making validated health technologies accessible and reimbursable for patients.

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Upcoming Events

[This Thursday] 18 July panel and Q&A – Beyond EtO: New EPA Regulations and Sterilization Alternatives , featuring Jessica Dreyer and Greg Murdock

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[Upcoming] 8 August panel and Q&A – RQM+ welcomes Michelle Tarver, MD, PhD , Deputy Center Director for Transformation, FDA , CDRH, for Advancing Health Equity with IVDs & Medical Devices: Regulatory Expectations & Action Plans.

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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

We've highlighted members of our CAPA facilitation team over the past two weeks. Links to individual LinkedIn features, two roundtable clips, and the full roundtable discussion are below.

• Elaine Ruminski , MS - Senior Consultant
• Craig McIntire - Senior Consultant
• Makenzie Dorring - Consultant, CMDA
• Joseph Commane - Consultant
• Key Skills Driving Client Success (LinkedIn Clip)
• Ideal Projects for Driving Innovation (LinkedIn Clip)
• Full Roundtable (Apple , Spotify , YouTube )

Europe

• First up in the Official Journal of the EU was the publication of Regulation (EU) 2024/1860 covering the extension to the IVDR transition timelines, enabling the gradual roll-out of the EUDAMED modules and introducing the new obligations for manufacturers to notify stakeholders of interruptions or discontinuations of the supply of certain medical devices. This was followed by a Q&A document on the IVDR transition timelines: EXTENSION OF THE IVDR TRANSITIONAL PERIODS. Q&A on practical aspects related to the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860 , and then an updated EUDAMED Timeline.
• The MDR transition Q&A document was also updated to reflect additional questions/answers given for in the IVDR, as well as clarifications and corrections: EXTENSION OF THE MDR TRANSITIONAL PERIOD AND REMOVAL OF THE ‘SELL OFF’ PERIODS. Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 .
• On that note, ANSM held a workshop with delegates from member states and the European Commission relating to the implementation of the MDR and IVDR , focusing on four areas: Governance, innovation, security and availability.
• Second up was the publication of what is commonly referred to as the EU AI Act but now has a new name….REGULATION (EU) 2024/1689...of 13 June 2024 laying down harmonised rules on artificial intelligence and amending...(EU) 2020/1828 (Artificial Intelligence Act)
• MDCG also provided an update to MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 .
• And MedTech Europe published their report for 2024: MedTech Europe’s Facts & Figures 2024 .
• In Ireland, the Minister for Health announced the establishment of a National Clinical Trials Oversight Group which is tasked with developing recommendations to increase the number of trials taking place in Ireland. The National Clinical Trials Oversight Group will propose sustainable solutions, with a view to creating more efficiencies in the clinical trials system. This will ensure Ireland can build on its excellent reputation across the clinical trials landscape and further position the State as a key strategic host in attracting international clinical trials.

United States and Canada

• Similarly, after a quiet first week of July, the FDA published several draft and final guidance documents of interest. First up is the final guidance on the Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder.
• There were then several draft guidance documents, including a Q&A on Addressing Misinformation About Medical Devices and Prescription Drugs . guidance on the Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products , and two 510(k) submission guidance documents for dental products: Dental Composite Resin Devices and Dental Curing Lights .
• The FDA also made the slides and recording from the recent Sterilization Town Hall available: FDA - Medical Device Sterilization Town Hall_Mock Pre - Submission on Implementing a Change in Sterilization Method

Rest of World

• World Health Organization (WHO) has introduced an online platform called MeDevIS (Medical Devices Information System) , the first global open access clearing house for information on medical devices. It is designed to support governments, regulators and users in their decision-making on selection, procurement and use of medical devices for diagnostics, testing and treatment of diseases and health conditions.

Recalls, FSCAs, and Alerts

Class I Recall (US)

• Electrode Pad Correction: Megadyne Issues Correction for MEGA SOFT, MEGA SOFT DUAL and MEGA 2000 Patient Return Electrodes to Limit Risk of Pediatric Burns
• Ventilator Software Correction: Hamilton Medical Issues Correction for HAMILTON-C6 Medical Ventilators to Address Risk of Failed Ventilation Restart
• An Implantable Hypoglossal Nerve Stimulator Device Removal: Inspire Medical Systems, Inc. Removes Inspire IV Implantable Pulse Generator due to Manufacturing Defect That Can Result in System Malfunctions
• Radiofrequency (RF) Coils Correction: Philips North America LLC Updates Use Instructions For SENSE XL Torso (1.5T And 3.0T) Coils Due to a Potential Issue Where the Coil Heats Up During MRI Scans, Possibly Leading to Thermal Injury
• Continuous Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions for BiPAP V30, BiPAP A30, BiPAP A40 Due to Interruptions and/or Loss of Therapy (Updated)

FDA Safety Communications

• Do Not Use Medtronic NIM Standard and Contact EMG Endotracheal Tubes - Letter to Health Care Providers
• Disruptions in Availability of BD BACTEC Blood Culture Media Bottles - Letter to Health Care Providers

Other FSCAs / Safety Notices

• Baxter Issues Urgent Medical Device Recall for Life2000 Ventilator Due to Potential Battery Charger Dongle Damage
• HeartSine Samaritan?PAD (Public Access Defibrillator) 350P/360P/450P/500P, Omron HDF-3500. Priority 2 – Warning (Ireland)
• FSNs published in the UK: Field Safety Notices: 1 to 5 July 2024 & Field Safety Notices: 24 to 28 June 2024

In the News

• Philips Was Correct In Disputed Death Reports, FDA Confirms (MedTech Insight)
• Philips recall of imaging coils tied to 12 injuries
• Medtronic recalls endotracheal tubes over blockage risk

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Warning Letters (United States)

• AG Essence, Inc. MARCS-CMS 678344 — JUNE 14, 2024 [Claims, classification, adulterated device] ?

Approvals and Clearances

• The World Health Organization (WHO) has prequalified the first hepatitis C virus (HCV) self-test which can provide a critical support in expanding access to testing and diagnosis, accelerating global efforts to eliminate hepatitis C .

In the news:

• Roche wins CE mark for its first CGM
• Pulse drops 510(k) plan for PFA device after FDA requests clinical data

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.

Europe Related

• Euro Roundup: EU updates MDR, IVDR to add obligations for companies facing supply problems (RAPS)
• MDCG guidance sets new classification rules for IVDs (RAPS)
• EU Guidelines On Justifying Phthalates In Medical Devices Applicable To Growing List Of Regulated Substances (MedTech Insight)
• UK Regulation: In A System Of Regulatory Reliance, PMS Assumes A Central Role (MedTech Insight)
• MDCG 2021-5 Rev. 1: EU’s Standardization Guidance Brought Up To Date (MedTech Insight)

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United States Related

• Lab industry seeks more flexibility in FDA emergency enforcement guidance (RAPS)
• FDA officials: Payers should be more involved in evidence generation ?(RAPS)
• FDA releases draft guidance on use-related risk analysis for combo products ?(RAPS)
• FDA draft guidance aims to give companies leeway to address medical misinformation ?(RAPS)
• FDA's LDT Overhaul Should Go Back To Congress, Appropriations Report Says (MedTech Insight)
• FDA Drops Final Guidance On Devices Designed To Treat Opioid Abuse (MedTech Insight)
• Orange Book Is The New Spat: FTC Seeks Removal Of ‘Improperly’ Listed Medical Device Patents (MedTech Insight)
• M.D. Georgia Unclutters Pelvic Mesh Complaint (Drug & Device Law Blog)
• Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight (FDA Law Blog)
• Better Late Than Never – Unpacking FDA’s Highly Anticipated (and Long Overdue) Draft Guidance on Diversity Action Plans (FDA Law Blog)
• Power to the Patient with Patient Generated Health Data (FDA Law Blog)
• FDA’s lab developed test rule could be first check on agency’s power post-Chevron

General Industry News

• WHO creates medical device database to encourage data consistency across borders (RAPS)

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