RQM+ Weekly Watch #23

RQM+ Recap

RQM+ news, recent content, and upcoming events.

New Technical Brief

Unpack chemical characterization of medical devices in our newest technical brief by Kevin Rowland . We think this brief serves as an efficient and friendly guide. Topics include:

• Overview of ISO 10993 standards
• Extractables and Leachables (E&L) testing
• Toxicological risk assessment
• Biological equivalence in the EU

🔬 Read the technical brief here 📖

Continuation of Clinical Trial Video Series

Videos cover three high-level areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. All videos in the series can be viewed on LinkedIn, our podcast (Apple, Spotify), and YouTube.

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
15. Secrets of Site Selection and Monitoring for IVD Studies (Part 1/2)
16. Secrets of Site Selection and Monitoring for IVD Studies (Part 2/2)

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 European Commission have published a report analysing cyber incidents in healthcare settings: Cyber security in the health and medicine sector: a study on available evidence of patient health consequences resulting from cyber incidents in healthcare settings.
• GMED's designation for the EU MDR 2017/745 is currently showing (last checked 16th Aug 2024) as expired. Their designation for the IVDR 2017/746 is still showing as active. This is more than likely a glitch with NANDO rather than GMED having lost their designation.
• The Swiss Federal Council announced that the Ordinance on In Vitro Diagnostic Medical Devices (IvDO) needs to be amended to align with the amended transitional arrangements for IVDs in the EU (as per Regulation 2024/1860). The official amendment of the IvDO is planned for autumn 2024.

United States and Canada

• The FDA have formally classified devices intended to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test as class II (special controls) devices. They will be covered under 21 CFR 866.3981 but until Part 866 (Immunology and Microbiology Devices) is updated, the special controls are listed in the Federal Register.
• Similarly, the FDA have formally classified devices intended to detect and identify selected microbial agents that cause acute febrile illness as class II (special controls) devices under 21 CFR 866.3966; and have classified intravenous catheter force-activated separation device into class II (special controls) under 21 CFR 880.5220. 
• FDA's CDRH also updated their guidance on how to obtain records from CDRH under the Freedom of Information Act (FOIA).
• The Centers for Medicare & Medicaid Services (CMS) issued a final procedural notice outlining a Medicare coverage pathway to achieve more timely and predictable access to certain new medical technologies for people with Medicare. The new Transitional Coverage for Emerging Technologies (TCET) Pathway for certain Food & Drug Administration (FDA)-designated Breakthrough Devices will increase the number of NCDs that CMS will conduct per year and should support both improved patient care and innovation by providing a clear, transparent, and consistent coverage process while maintaining robust safeguards for the Medicare population. 

Rest of World

• The WHO have declared mpox outbreak a public health emergency of international concern.
• TGA have opened a consultation on whether the Australian Essential Principles (Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002) should be aligned with the GSPRs of the EU MDR and IVDR. The consultation is closes on 16 October 2024.

Recalls, FSCAs & Alerts

Class I recall (US)

• None this week.

FDA Safety Communications

• None this week.

Other FSCAs / Safety Notices 

• None this week.
• FSNs published in the UK: Field Safety Notices: 5 to 9 August 2024

In the News

• Breas Medical flags risk of formaldehyde exposure in ventilators
• Tandem’s Mobile App Still Causing Battery Depletion Post-Update

Warning Letters (United States)

• Baylab USA, LLC MARCS-CMS 679001 — June 27, 2024 [Adulterated, misbranded, Design Control, Supplier Management, Complaint handling, Medical Device Reporting, UDI] 
• Globus Medical, Inc. MARCS-CMS 685606 — July 15, 2024 [CAPA, Complaints management, Medical Device Reporting]

In the news:

• FDA warns surgical robot maker Globus for QSR, MDR violations (RAPS)
• Globus receives warning letter over spine navigation robot

Approvals, Clearances, and Classifications

• PGDx elio plasma focus Dx - DEN230046 (Personal Genome Diagnostics, Inc.)
• VerTouch Spinal Imaging Device - DEN220009 (IntuiTap Medical, Inc.)
• Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 RESILIA Transcatheter Heart Valve System - P140031/S162 (Edwards Lifesciences, LLC)

In the news:

• Medtronic wins FDA approval for asleep deep brain stimulation
• Medtronic Wins FDA Approval For Asleep DBS, Easing Parkinson’s Patients’ Fears Of Awake Brain Surgery

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

• Creating a Circular Eco-System for Medical Devices: Eco-Design (BSI)
• Dermanostic: A Legal Guinea Pig Impacted By MDR’s Regulatory Gaps? (MedTech Insight)
• EU Experts Vollebregt and Melvin Agree Over Nature Of Changes Needed To MDR (MedTech Insight)

United States Related

• FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA) (Drug Delivery Leader)
• New Consensus on the Sterilization of Single-Use Systems for Manufacturing (AAMI)
• Slam-Dunk Express Preemption Decision from the District of Arizona (Drug & Device Law Blog)
• More Stuff to Use in Litigating Amended Rule 702 (Drug & Device Law Blog)
• Advances In Reimbursement: Prostate Cancer AI Mapping Receives CPT Code (MedTech Insight)
• Medical Diagnostic Equipment Accessibility Regulations Announced by DOJ Under Title II of ADA (Health Law Advisor Blog)
• CMS finalizes notice on Medicare coverage for breakthrough devices (MedTech Dive)

General Industry News

• Medical Device Post-Market Surveillance: The 7 Deadly Sins to Avoid (AAMI)
• QARA Professionals Question a Future with Cybersecurity Issues, US Litigation, and the EU AI Act (BioSpace)

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