RQM+ Weekly Watch #2

This newsletter contains information published through the previous Friday.

RQM+ Recap

RQM+ content published last week and upcoming events.

Technical Briefs

• Streamlining AE Reporting in PMCF Studies (FDA Perspective)
• 8 Strategic Advantages of Outsourcing Audits
• What are Extractables and Leachables?

Video/Audio

• How can AI support regulatory efforts? (IVD focus) | LinkedIn
• Fern.ai extraction framework feature overview | LinkedIn
• Excellence Spotlight: Kaitlin Lerner, Lab Services Director of Operations | LinkedIn, Apple Podcasts, Spotify

Upcoming

• 28 March RQM+ Live! #77 presentation and panel – Get Ahead of the Crisis: How Your Quality System Can Prevent Negative Impacts on Customers, Patients, and Reputation
• 16 April presentation and Q&A – Aligning Your QMS with the FDA's QMSR Updates

Europe

• The presentation of the most recent Notified Body survey on applications and certifications was revised on 11 March 2024, with minor adjustments in some of the charts.
• MDCG published guidance on, and a template for, the Clinical Investigation Plan under the EU MDR. See also MDR Annex XV Chapter II, and Annex A of ISO 14155:2020.
• — MDCG 2024-3 Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices
• — MDCG 2024-3 Clinical Investigation Plan Synopsis Template
• GMED's latest newsletter turns the spotlight onto Periodic Safety Update Reports (PSURs) providing some guidance and insights into the common issues that they see in manufacturer's submissions to date.
• The Artificial Intelligence (AI) Act is now finalized:
• — Artificial Intelligence Act: MEPs adopt landmark law
• — MedTech Europe - Medical technology industry perspective on the final AI Act
• MedTech Europe also published two further press releases/statements last week:
• — Climate Risk Assessment confirms urgency of addressing systemic risks to health systems
• — MedTech Europe views on the ‘One Substance, One Assessment’ European Commission package of legislative proposals
• The European Chemicals Agency (ECHA) have published the outline of their next steps for PFAS restriction proposal.
• Further to the recent MHRA’s recently published roadmap for new medical device regulations, Dr Laura Squire OBE, Chief Health Quality and Access Officer at the Medicines and Healthcare products Regulatory Agency (MHRA) joined the ‘From the frontline podcast’ to discuss the MHRA's plans and intentions.
• —?Inside the MHRA’s roadmap for new MedTech Regulations: Ensuring Safety and Driving Innovation. This podcast was recorded in February 2024, before the recent MHRA webinar on the Scope, Classification and Essential Principles aspects of the future regulations.
• The independent review of equity in medical devices was published last week, and the MHRA swiftly published their response to the report:
• — Equity in medical devices: independent review - final report
• — MHRA response to Equity in Medical Devices: Independent Review
• The UK Government published updated guidance on the classification of wheeled mobility devices (e.g. powered wheelchairs and mobility scooters) with regards to where those devices can be used legally. The guidance clarifies what other items need to be in place before appropriate mobility devices can be used on roads.

United States and Canada

• The FDA's CDRH welcomed the 25th Session of the International Medical Device Regulators Forum (IMDRF) where one of the key themes was Reliance (i.e. the use of assessments and approvals performed by one regulatory authority to support decision-making by another regulatory authority).
• The FDA published three new draft guidance documents:
• — Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling
• — Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act - Draft Guidance for Industry and Food and Drug Administration Staff
• — Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Draft Guidance for Industry and Food and Drug Administration Staff
• The FDA also published a report outlining how the different parts of the FDA are collaborating on the subject of artificial intelligence: Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.
• On March 14, 2024, EPA announced final amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Ethylene Oxide Commercial Sterilizers.?

Rest of World

• Kenya's Pharmacy and Poisons Board is now listed as a new MDSAP Affiliate Member.

Recalls, FSCAs, and Alerts

Class I Recall (United States)

• Avanos Recalls MIC Gastric – Jejunal Feeding Tube Kits Containing Sterile Water Based Products Under Recall by Nurse Assist
• Windstone Medical Packaging, Inc. Recalls Local Lower Extremity Pack, In House Ocular Pack and Closure Kit Containing Sterile Water Based Products Under Recall by Nurse Assist
• Abbott Recalls HeartMate Touch Communication System for Unintentional Pump Start and Stop

FDA Safety Communications: None this week.

European FSCAs / Safety Notices

• MAGEC X System, NuVasive Specialized Orthopedics (NSO): UK suspension lifted, (DSI/2024/002)
• FSNs published in the UK: Field Safety Notices: 4 to 8 March 2024

?

Warning Letters (United States)

• Exactech, Inc. MARCS-CMS 669904 — JANUARY 19, 2024 - CAPA, Design Validation, Risk Management, Medical Device Reporting
• Nobles Medical Technology II, Inc. MARCS-CMS 673465 — JANUARY 26, 2024 - Clinical Investigation ?

Approvals and Clearances

• Restylane Eyelight – P040024/S135
• SKINVIVE by JUVéDERM – P110033/S059
• TOPS System – P220002
• SurVeil Drug-Coated Balloon – P210025
• HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads – P200007
• AAV5 DetectCDx – P190033
• Optilume BPH Catheter System – P220029
• CraniSeal Dural Sealant – P220014
• PALMAZ MULLINS XD Pulmonary Stent – P220004
• Minitouch 3.8 Era System – P230002
• Boston Scientific Cardiac Cryoablation System – P220032
• LimFlow? System - P220025

Articles We Read

Europe Related

• AI and Product Safety Standards Under the EU AI Act
• The impact of the EU IVDR on clinical trials
• Proposal on health data access for research falters over patient consent

?United States Related

• FDA proposes updates to device cybersecurity guidance
• EO Sterilization: FDA and Industry Weigh the Future
• Bumpus discusses adcomms, animal testing, and AI
• Industry advises FDA not to issue more guidances without public comment
• Harmonization in the Spotlight: FDA’s Melissa Torres on IMDRF and Growing Global Outreach in 2024
• AI oversight is top challenge facing global device regulators: FDA official
• Experts discuss how to avoid STeP, breakthrough device submission missteps
• This Week at FDA: Another budget cliffhanger, new adcomm, and a missed EtO deadline
• EPA finalizes rule to reduce EtO emissions from sterilization facilities
• Getting it Right on PMA Preemption

?General Industry News

• Addressing the Total Product Lifecycle: Sustainability, Supply Chain, and Resilience
• IMDRF: Regulators offer updates on new working group documents
• Addressing the Total Product Lifecycle: Sustainability, Supply Chain, and Resilience
• IMDRF: Regulators offer updates on new working group documents
• IMDRF: Regulators offer updates on new working group documents
• Stakeholders discuss potential IMDRF reliance playbook, guidance
• Just Published: A Five-Year Health Industry Cybersecurity Strategic Plan for Everyone
• Medical device bias needs immediate action - review
• Roche unveils new CGM tech with predictive AI, outlines diabetes strategy

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