RQM+ Weekly Watch #24

RQM+ Recap

RQM+ news, recent content, and upcoming events.

?? Big Names to Discuss MDR/IVDR In Next Week's Panel

Join the panel to explore the implications for manufacturers due to the MDR and IVDR amendments and hear ???????????????????? strategies to ensure compliance. Our expert panel – 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.

?? Join the panel discussion here ?

A New Foundation of Leadership at RQM+

We’re thrilled to announce the key leadership appointments of both Ronnie Mahofski and Kevin Rowland to Executive Vice President and General Manager. In their new roles, Ronnie will be leading our RA/QA Consulting Services and Fern.ai business units, while Kevin will head Jordi Labs, an RQM+ Company , an RQM+ Company.

?? “?????????? ?????????????????? ???????????????????? ?????????????? ???????????????????? ?????? ???????????????????? ???? ?????????????????? ???? ?????? ???????????????????????? ???????? ???????? ???????? ??????+ ?? ?????????????? ???? ?????? ?????????????? ????????????????.” – John Potthoff , CEO.

?? Read the full release ??

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 .

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

Europe

• The European Commission have published a draft amendment to the Common Specifications for IVDs . Once finalised and published, this would update Regulation (EU) 2022/1107 . Key things to note in this draft amendment are: the definition of 'virus typing device' is amended, swapping 'samples' for 'specimens'; editorial tweaks have been made throughout existing Annexes I to XIII (described in Annex I of the draft amending regulation); and seven (7) new annexes have been added to cover common specifications for devices intended for detection or quantification of markers of hepatitis E virus (HEV) infection, devices intended for detection or quantification of markers of Toxoplasma gondii infection, devices intended for detection of markers of Plasmodium infection, devices intended for detection or quantification of markers of Chikungunya virus (CHIKV) infection, devices intended for detection or quantification of markers of dengue virus (DENV) infection, devices intended for detection or quantification of markers of West Nile virus (WNV) infection and devices intended for detection or quantification of markers of Zika virus (ZIKV) infection. Once finalised, the amending regulation enters into force 20 days after publication in the OJEU. The date of application is two years after the entry into force.
• The UK's MHRA have opened a public consultation on the statutory fees charged by the MHRA to recover the costs of its activities. Proposals of note for device manufacturers:
• — notification fees (initial and resubmission) for clinical investigations would be approximately doubled;
• — annual registration fees will change from a flat fee to a ￡210 fee per GMDN registration;
• — a new service providing regulatory advice meetings for medical devices at ￡987 for a one hour meeting.
• The recording of the MHRA's webinar “AI Airlock – the Regulatory Sandbox for AIaMD in healthcare ” which took place on Tuesday 23 July 2024 is now available to view.
• The UK's NICE have issued draft guidance stating that the variation in price the NHS is paying for valves used in keyhole heart procedures is not supported by reliable evidence .
• The ANSM and the French Society of Medical Physics (SFPM), in conjunction with the dedicated working group (GT radiotherapy), are launching a public consultation on the draft revision of the quality control decision for external radiotherapy and radiosurgery installations .
• Swissmedic updated their information sheet on the topic of 3D printers medical devices (MU600_00_017e)

United States and Canada

• The FDA issued final guidance on Acceptable Media for Electronic Product User Manuals.
• FDA issued this final guidance: Electronic Submission Template for Medical Device De Novo Requests . This guidance builds on the guidance Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act . Starting 1st October 2025, all De Novo Requests, unless exempted, must be submitted as electronic submissions using eSTAR.
• FDA issued the final guidance Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers to help manufacturers understand and participate in the VMSR program. The guidance intends to further explain, but not change, the conditions of the VMSR program. This guidance describes the conditions of when individual malfunction reports may be required—instead of summary reports—for devices that are ineligible for the program, such as when individual reports are necessary to address a public health issue.
• FDA issued this draft guidance Predetermined Change Control Plans for Medical Devices . This draft guidance proposes a policy for predetermined change control plans (PCCPs) and recommendations on the information to include in a PCCP in a marketing submission for a device (any device, not just AI or ML-enabled medical devices).?
• The FDA issued final guidance on the Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide . This Small Entity Compliance Guide (SECG) is intended to explain the actions a small entity is required to take to comply with the MQSA rule and its implementing regulations. The SECG also includes policy and recommendations previously found in the Policy Guidance Help System.?
• FDA has classified the neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness.?
• FDA has classified the digital therapy device for Attention Deficit Hyperactivity Disorder as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness.?
• FDA has classified the intervertebral body graft containment device as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness.?
• FDA has classified the external compression device for internal jugular vein compression as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness.?
• The FDA have updated their Frequently Asked Questions on the incoming Quality Management System Regulation (QMSR) and have published two new modules in CDRH Learn relating to the QMSR: Overview of Quality Management System Regulation and Navigating the Quality Management System Regulation
• FDA has begun building a surveillance system to look for potential safety issues in such devices. It plans to start with a few devices and expand over time: Medical Devices: FDA Has Begun Building an Active Postmarket Surveillance System .?

Rest of World

• Further to the recent declaration of the mpox outbreak being a public health emergency of international concern, WHO has asked manufacturers of mpox in vitro diagnostics (IVDs) to submit an expression of interest?for Emergency Use Listing (EUL) . WHO has been in ongoing discussions with manufacturers about the need for effective diagnostics, particularly in low-income settings. The request for EUL expressions of interest by manufacturers is the latest development in these discussions.
• ISO have published their latest list of draft and final standards, here . Recent publications of note: ISO 5362:2024 Anaesthetic and respiratory equipment – Anaesthetic reservoir bags; ISO 17256:2024 Anaesthetic and respiratory equipment — Respiratory therapy tubing and connectors; ISO 7197:2024 Neurosurgical implants — Sterile, single-use hydrocephalus shunts; ISO 5910:2024 Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices; ISO 23500-2:2024 Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies; and ISO 80369-2:2024 Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors for respiratory applications.

Recalls, FSCAs & Alerts

Class I Recall (US)

• Infusion Pump Battery Correction: ICU Medical Updates Instructions for Use Regarding Batteries in Plum 360, A+ and A+3 Infusion System due to Diminished Battery Life that May Impact Infusion Delivery
• Chest Compression Device Recall: Defibtech, LLC, Removes RMU-2000 ARM XR Chest Compression Device due to Risk of Device Stopping Compressions
• Clot Removal Device Correction: Inari Medical Updates Use Instructions for ClotTriever XL Catheter due to Reports of Patient Injury and Death from Device Entrapment and Pulmonary Emboli

FDA Safety Communications

• Voluntary Recall of SoClean Equipment Intended for Use with CPAP Devices and Accessories: FDA Safety Communication (Updated)

Other FSCAs / Safety Notices

• Philips Respironics BiPAP A series ventilators: alarm malfunction and risk of therapy interruptions in ventilators not intended for life-support, DSI/2024/006 (UK)
• SN2024(04) McGrath MAC Video Laryngoscope - Priority 1 - For Immediate Action (Ireland)
• Medical devices affected by 3G network closure (Australia)
• FSNs published in the UK: Field Safety Notices: 12 to 16 August 2024 & Field Safety Notices: 19 to 23 August 2024

In the News

• Six Deaths Linked To Inari Clot Removal Device
• Inari updates label of clot removal device linked to 6 deaths
• Defibtech recalls chest compression device linked to patient death

Warning Letters (United States)

• Shenzhen Moyeah Intelligent Life Technology Co. ? [Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device]
• LEEL Tech ?[Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device]
• Natures Pillows, Inc. and Top Dog Direct, LLC [Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device]
• Adventure Innovations LLC [Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device]

Approvals, Clearances, and Classifications

For Classification:

• SoClean 3+ Bacterial Reduction Device - DEN210037 (SoClean, Inc.)

BD Onclarity HPV Assay - P160037/S017 (Becton, Dickinson and Company)

ColoSense – P230001

De Novo Decision Summaries added:

• DEN230008
• DEN210035
• DEN190038
• DEN220082
• DEN210039
• DEN190035
• DEN230007
• DEN220063
• DEN220065
• DEN200011
• DEN220044
• DEN210022
• DEN200067
• DEN210027
• DEN200062

In the news:

• Bleep Bloop Blood: Vitestro’s Automated Blood-Drawing Robot Cleared For EU Market
• NOWDiagnostics Wins De Novo For First OTC Syphilis Test
• Embecta gets FDA nod for insulin patch pump
• Illumina wins FDA approval for companion diagnostic cancer test
• Boston Scientific receives CE mark for updated TAVR technology
• Insulet expands Omnipod 5 pump to people with Type 2 diabetes
• Procept wins FDA clearance for updated prostate surgery robot
• Stereotaxis earns CE mark for new surgical robot

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

• EU Regulatory Roundup, August 2024: Need For MDR Changes Continues To Absorb Sector (MedTech Insight)
• EU Launches Call For Regulatory Sandbox Initiative To Accelerate Medtech Innovation (MedTech Insight)
• Early Diagnosis Law Targeting Risk Factors Is Answer To Germany’s Spiralling CVD Costs (MedTech Insight)
• EU Needs Feedback On Draft Requirements For Seven High-Risk IVD Test Categories (MedTech Insight)
• Criticisms About EU MDR’s Rule 11 For Software Classification Are ‘Unfounded’ (MedTech Insight)
• European Commission Publishes Links To Notified Bodies’ Medtech Fees (MedTech Insight)
• Evidence Lacking On How Cyber Attacks Impact Patients (MedTech Insight)
• From claim to confirmation: how to properly define clinical benefits for SaMD (Scarlet)
• What’s Next for the UK’s Harmonization Efforts? (AAMI)

?

United States Related

• FDA Announces Four New Device Classifications (MedTech Insight)
• US Government Set To Relaunch Free At-Home COVID-19 Tests Program (MedTech Insight)
• Final Guidance Details FDA’s Summary Reporting Program (MedTech Insight)
• California To Ban DEHP In IV Bags, Tubing With Phased Compliance Deadlines (MedTech Insight)
• Final Guidance Sets Date For Mandatory De Novo Electronic Submissions (MedTech Insight)
• FDA Drops Draft Guidance on Predetermined Change Control Plans for Medical Devices (MedTech Insight)
• Shuren Faces Calls For Investigation On Conflict Of Interest Claims (MedTech Insight)
• FDA To Expand Postmarket Surveillance Of Medical Devices, Per GAO Report Requested By Lawmakers (MedTech Insight)
• Survey: Panelists Open To Advisory Committee Reforms (MedTech Insight)
• Device Classifications For COVID, Acute Febrile Illness IVDs And Force Separation Catheters (MedTech Insight)
• Finding FDA authorized devices with Predetermined Change Control Plans (MedTech Dive)
• Pathology group sues to block FDA lab test rule (MedTech Dive)
• FDA finalizes Voluntary Malfunction Summary Reporting guidance (MedTech Dive)
• FDA seeks feedback on predetermined change control plans (MedTech Dive)
• FDA’s plan to expand device surveillance faces challenges, GAO finds (MedTech Dive)
• Biden pledges $150M for medical tech to improve cancer surgery (MedTech Dive)
• Possible Learned Intermediary Showdown in Michigan (Drug & Device Law Blog)
• Snap Removal, and TwIqbal, and Preemption-Oh My (Drug & Device Law Blog)
• Doctors use problematic race-based algorithms to guide care every day. Why are they so hard to change?
• Long Time Passing: Where Have All the De Novo Decision Summaries Gone? (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