RQM+ Weekly Watch #12

RQM+ Recap

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

News

• RQM+ Launches Fern.ai Smart Authoring Module for MedTech | Press Release , LinkedIn

Technical Briefs

• FDA Proposed Rule: Impact on Wound Care Devices

Video/Audio

• [Now On Demand] David Novotny was a guest on THREAD webinar – Modernizing MedTech Research via Hybrid Study Approaches to Enhance Your Patient Recruitment
• [Now On Demand] Held presentation and Q&A – We Need to Talk About Risk: The Critical Role of Communication in Risk Management
• RQM+ Launches Fern.ai Smart Authoring Module for MedTech (Walkthrough Video) | LinkedIn

Upcoming Online Events

• [RQM+ Live! #79] 6 June panel and Q&A – FDA's Wound Care Shakeup: Ensuring Your Products Make the Cut , featuring Allison Komiyama, PhD, RAC , Mark DuVal, J.D. FRAPS , Jonathan Gimbel , and Erin Gontang

• [Webinar] 20 June – Adapting to the New LDT Regulatory Reality: The Path to Compliance , presented by Margot Borgel, Ph.D. and Bethany Knorr Chung, PhD, RAC

Europe

• The Council of the EU approved a ground-breaking law aiming to harmonise rules on artificial intelligence, the so-called artificial intelligence act .?
• Taylor Wessing have launched an online tool to help companies navigate European advertising regulations: Advertising Medical Devices European Comparison Tool .
• The EMA have updated their Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746) , with a tracked changes version available too. This question-and-answer document provides practical considerations on the implementation of the medical devices and in vitro diagnostic regulations for combinations of medicinal products and medical devices.
• The MHRA published a Statement of policy intent on the international recognition of medical devices . This statement lays out the MHRA's intent with regards to recognition of devices that have been accepted/approved/cleared by other trusted regulatory authorities (referred to as Comparable Regulator Countries, CRC). This is a draft proposal that outlines what is likely to be included in the future UK medical device regulations (publication of draft is expected late 2024, with final publication and entry into force in 2025), but it may be subject to change. In fact, there are still many unknowns and questions to be answered based on this draft, especially on who is doing all of these activities and how it will be maintained. In summary; devices ‘approved’ for the Australian, Canadian or US markets can access the GB market via one of 4 routes depending on which CRC ‘approval’ they are leveraging, the conformity assessment route they used and the difference in classification between the CRC and the MHRA. UK specific requirements will be in place but the proposal indicates an abbreviated assessment even for the groups of devices carrying more uncertainty (e.g. the proposed policy shows a dislike for any use of equivalence). Team-AB published their thoughts on the MHRA's policy intent: here . This has a welcoming sentiment, but includes a warning about not compromising the need to ensure patient safety. BIVDA welcomed the MHRA's statement of intent . The announcement on Wednesday 22nd May that there will be a general election in the UK on 4th July may adversely affect the planned timelines, especially for the expected PMS SI that was due to be published in the first half of 2024.
• And also in the UK, the written judgement of an appeal case were published . This case involved BSI and device manufacturer RRR, and centres around the safety and conformity of the device. There are a lot of elements, but the specifics of the case, the background events and the legal arguments made are very interesting and should be considered as the MHRA and Team-AB finalise the process for international recognition.
• The MHRA has also launched a four-week consultation which will support improved safety for certain high risk in vitro diagnostic (IVD) devices. The MHRA are seeking views on the introduction of common specification requirements to the regulatory framework before IVD devices can be placed on the GB market. We are also seeking views on the removal of the Coronavirus Test Device Approval (CTDA) process to avoid duplication of regulatory requirements for COVID-19 tests against the Common Specification requirements.
• MedTech Europe 's MedTech Forum took place this week and there are various reports of the proceedings: here .
• The Biomedical Alliance in Europe has published a statement on finding a balance between implementing PFAS restrictions and the need for continuous access to life-saving devices .

United States and Canada

• The FDA have published a final order to reclassify ultrasound cyclodestructive devices from class III into class II and to establish special controls by revising 21 CFR part 886. In this final order, the Agency has identified the special controls under section 513(a)(1)(B) of the FD&C Act that, along with general controls, provide a reasonable assurance of the safety and effectiveness for ultrasound cyclodestructive devices: Federal Register:?Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device
• U.S. Secretary of Commerce Gina Raimondo released a strategic vision for the U.S. Artificial Intelligence Safety Institute (AISI) . The National Institute of Standards and Technology (NIST) within the Department of Commerce launched the AISI, building on NIST’s long-standing work on AI.
• The Clinical and Laboratory Standards Institute (CLSI)'s CEO provided a positive outlook in response to the FDA's final rule on Laboratory Developed Tests .

Rest of World

• Nothing significant to report. ?

Recalls, FSCAs, and Alerts

Class I Recall (US)

• Hologic, Inc. Recalls BioZorb Marker Due to Complications with Implanted Devices

FDA Safety Communications

• UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication (Updated)
• Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results: FDA Safety Communication

Other FSCAs / Safety Notices

• FSNs published in the UK: Field Safety Notices: 13 to 17 May 2024

In the News

• FDA issues import alerts against 2 more plastic syringe manufacturers

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Warning Letters (US)

Approvals and Clearances

• restor3d Total Talus Replacement - H230003 (restor3d, Inc.)
• Duo Venous Stent System - P230021 (Vesper Medical, Inc.)
• TZ Medical Adult and Pediatric Multi-Function Defibrillation Electrodes and Adaptors - P200005 (TZ Medical, Inc.)

Articles We Read

Europe Related

• Notified bodies concerned with lack of MDR/IVDR applications as deadlines approach (RAPS)
• MHRA proposes recognition path for devices cleared by trusted regulators (RAPS)
• EMA revises Q&A guidance on drug-device combination products (RAPS)
• EMA updates advice on drug-device combinations under MDR, IVDR

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United States Related

• FDA concerned about potential device shortages due to new EtO limits (RAPS)
• E.D. Pa Delivers Dismissal of Product Liability Claims vs. Retailers (Drug & Device Law Blog)
• No Standing for No Injury Medical Monitoring Claim in West Virginia Federal Court (Drug & Device Law Blog)
• The Non-Existent Tort of “Failure To Recall” (Drug & Device Law Blog)
• FDA seeks AI tech to predict, detect Parkinson’s symptoms
• Guardant colon cancer test struggles to detect non-cancerous tumors, FDA says
• When Worlds Collide: The Theory of Real-World Evidence Meets Reality – Part II

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General Industry News

• None to report this week.

Stay In the Know

• Subscribe to the RQM+ Device Advice podcast (Apple , Spotify , Google )
• Visit the RQM+ Knowledge Center for upcoming and on-demand content
• Follow RQM+ on LinkedIn for regular updates