RQM+ Weekly Watch #30

RQM+ Recap

RQM+ news, recent content, and upcoming events.

?? Shattering Barriers: New Health Equity White Paper

Hot off the heels of our panel discussion with FDA /CDRH Acting Director and Deputy Center Director for Transformation, Michelle Tarver, MD, PhD , our brand new white paper authored by Jaishankar Kutty, Ph.D. dives into the essential role of diversity in clinical trials. We explore how inclusive research practices can lead to safer, more effective medical devices for all populations. Questions to consider:

• Are your outdated trial designs setting you up for failure, or are you ready to revolutionize your approach?
• Is your technology stack truly equipped to handle the complexities of modern clinical trials, or are you just patching leaks?
• Are your recruitment tactics quietly excluding the very populations that could make or break your trial’s success?
• Is your clinical trial truly reflective of diverse real-world scenarios, or are you just playing it (un)safe?

?? Read the White Paper Here ??

In-Person Events

See the complete list here. ??

Featured Event ? The MedTech Conference ( AdvaMed ) is happening NOW in Toronto, Canada. Please visit us at booth 631 right by the hockey challenge and food court to meet our team! Our team members onsite are John Potthoff, Margot Borgel, Ph.D., Amie Smirthwaite, PhD, FRAPS, Allison Komiyama, PhD, RAC, Stormie R. Crouch, Matthew Burger, Ronnie Mahofski, and Victoria Chester Rose.

Europe

• The European Parliament discussed the implementation of the EU MDR during a plenary session on 9th October 2024. and will revisit the topic on 23rd October 2024 to agree on a resolution. This comes on the back of the Mission letter sent to Oliver Varhelyi (Commissioner designate for health and animal welfare) by the President of the European Commission, Ursula von der Leyen. COCIR and MedTech published their views on this letter a few weeks ago, in addition to their own individual positions on the areas for improvement (COCIR and MedTech Europe). In response to European Parliament's plenary session, the Biomedical Alliance in Europe published their own views on the matter in this press release. Included in their response is a warning against the implementation of “short-term legislative measures without a careful diagnosis of the key shortcomings in the system” whilst also highlighting the need for the implementation of "targeted short-term measures to reduce certification costs and mitigate shortages of medical devices". Read on more on this plenary session from MedTech Insight here: Get It Done In 100 Days: European Commission Told To Deliver On Revising Device Regulation and EU’s Medtech Rules Are A 'Bureaucratic Monster,' European Parliamentarians Say.
• Commission Implementing Decision (EU) 2024/2631 and Commission Implementing Decision (EU) 2024/2625 were published, updating the lists of harmonized standards for the EU MDR and IVDR. EN ISO 13408-1:2024 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023) is now officially harmonized for both the MDR & IVDR, and EN ISO 20916:2024 In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice (ISO 20916:2019)’ is now officially harmonized for the IVDR.
• The 50th Notified Body was designated for the EU MDR, NEOEMKI LLC.
• MDCG published two new guidance documents; MDCG 2024-11 Guidance on qualification of in vitro diagnostic medical devices and MDCG 2024-12 Corrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified ?bodies, designating authorities and joint assessment teams.
• The Health and Youth Care Inspectorate (IGJ), in the Netherlands, published their findings from inspections conducted during 2023 and 2024 and have called upon medical device manufacturers to implement an effective PMS system and meet the MDR/IVDR PMS requirements. None of the 13 manufacturers visited by the IGJ in 2023 and 2024 met the PMS requirements. The inspections focused primarily on micro, small, and medium-sized enterprises, covering Class I medical devices, software applications, and in-vitro diagnostics (IVDs) that are being marketed as legacy devices. Key concerns from the IGJ were:
• — Not all manufacturers fully grasp the purpose and mindset behind PMS.
• — PMS is partially implemented, but the plan is not well-developed.
• — Manufacturers have limited knowledge, skills and focus regarding the purpose of PMS.
• — The PMS system is not tailored to the specific type of medical device.
• — Many PMS plans or underlying procedures lacked suitable indicators and threshold values for the various data sources.
• — Manufacturers lack a clear understanding of when action is needed based on PMS.
• BSI have updated their publication summarizing capacity and lead times for EU Notified Body services. There appears to be a decrease in the lead time for the orthopedic and dental team and a slight increase in the lead time for most of the medicinal and biologics team.
• ABHI and CPI published their 2024 ‘Pulse of the Sector’ survey report. The survey findings highlight:
• The MHRA published guidance on what kind of issues to report for the users of insulin pumps and continuous glucose monitoring equipment, and how to report these issues to the MHRA.
• The MHRA have also published a new business plan for 2024/25 with a focus on transparency, communication, addressing healthcare inequalities, access to safe & effective products, and scientific & regulatory excellence.
• On a similar theme, the UK's Science Secretary has launched a new Regulatory Innovation Office (RIO) that will help regulators such as the MHRA to update regulations and reduce the burden for businesses aiming to get innovative products on the UK market.

United States and Canada

• The FDA have published a correction to the final rule for the medical device cGMPs (i.e. 21 CFR 820, QSR/QMSR). The term and definition for ‘batch or lot’ was unintentionally omitted from the final rule that was published in February 2024. This correction is inserting the term and definition into 21 CFR 820.3 as follows: ‘‘Batch or lot means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.’’. The term and its definition is the same as that currently used in 21 CFR 820.3 (m).
• The FDA's CDRH have released their plans for guidance publications for the fiscal year (FY) 2025. When looking at the FY 2024 list, CDRH published 15 of the 24 items on the list (in Final or Draft form as per their list) and the remaining 9 have been transferred over to the FY 2025 list. During FY 2025 we can expect to see more final or draft guidance on evidence required for 510(k) submissions, more guidance related to IVDs and LDTs, medical device shortages, AI/ML lifecycle management considerations and recommendation and computer software assurance. New for the FY 2025 list is the addition of an ‘Under Construction’ list. According to CDRH “This list identifies the guidance documents that CDRH intends to develop as resources permit that are not on the A- or B-list. The “Under Construction” list does not represent the totality of guidances CDRH intends to develop, but is intended to promote transparency to interested parties. ”
• Further to the recent publication of several guidance documents relating to the safety and performance based pathway, CDRH have now also released final guidance for Endosseous Dental Implants and Endosseous Dental Implant Abutments.

Rest of World

ISO released their monthly list of published standards (01 September - 30 September) Of note for the MedTech industry are:

• ISO 8536-13:2024 Infusion equipment for medical use — Part 13: Graduated flow regulators for single use with fluid contact
• IEC 80601-2- 49:2018/Amd 1:2024 Medical electrical equipment — Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment — Amendment 1
• ISO 14630:2024 Non-active surgical implants — General requirements
• ISO 7199:2024 Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)
• ISO 20342-5:2024 Assistive products for tissue integrity when lying down — Part 5: Test method for resistance to cleaning and disinfection
• ISO 80369-2:2024 Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors for respiratory applications
• ISO/TS 22583:2024 Requirements and recommendations for supervisors and operators of point-of care testing (POCT) equipment

Recalls, FSCAs, and Alerts

Class I Recall (United States)

• Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitators due to Risk of Inline Controller Detachment that May Impact Ventilation
• Infusion Pump Recall: Zyno Medical Removes Certain Z-800, Z-800F, Z-800W, and Z800WF Infusion Pumps due to an Air-in-Line Software Defect That May Allow Larger than Expected Air Bubbles to Enter Patients

FDA Safety Communications

• None this week.

Other FSCAs / Safety Notices

• FSNs published in the UK: Field Safety Notices: 7 October to 14 October 2024

In the News

• Medtronic recalls MiniMed insulin pumps over drained batteries?
• Mercury Medical recalls emergency resuscitators (MedTech Dive)
• Medtronic recalls Minimed insulin pumps for reduced battery life (MedTech Dive)
• Smiths recalls ventilators over risk of oxygen flow disruption (MedTech Dive)
• Tracking Philips Respironics recalls (MedTech Dive)

Warning Letters (United States)

• None this week.

Approvals, Clearances, and Classifications

• MYNX Control? Venous Closure Device (VCD) - P040044/S097 (Cordis US Corporation)
• UNIPURE C3F8 Ophthalmic Gas, UNIFEYE Gas Delivery System, UNIPLEX Gas Delivery System - P220030 (Alcon Research,?LLC)
• SHIELD - P230009 (Guardant Health, Inc.)

Articles We Read

Note: Some articles are behind a paywall (MedTech Insight) and are clearly noted.

?

Europe Related

• Get It Done In 100 Days: European Commission Told To Deliver On Revising Device Regulation (MedTech Insight)
• EU’s Medtech Rules Are A 'Bureaucratic Monster,' European Parliamentarians Say (MedTech Insight)
• Hungary’s New Designation Pushes EU Medical Device Notified Body Count To 50 (MedTech Insight)
• EU's MDCG Releases Corrective And Preventive Action Plan Guidance For Notified Bodies (MedTech Insight)
• MDCG issues guidance and templates on CAPA plans (RAPS)?

?

United States Related

• Cybersecurity And LDT Enforcement Top FDA’s Guidance Priorities for 2025 (MedTech Insight)
• College of American Pathologists Supports FDA’s Role In LDTs, Not Its Rule (MedTech Insight)
• PCCPs Can Help Speed Device Sterilization Changes, FDA Webinar Suggests (MedTech Insight)
• Opinion: The Only Thing That’s Permanent in Life Is Change (MedTech Insight)
• 240 Global Regulators and Industry Partners Gather in Providence for Combination Products Summit 2024 (RAPS)
• FDA compliance official highlights priorities, return to onsite inspections, and warning letter trends (RAPS)
• The HHS Reorg: Streamlining Cybersecurity, Data, and AI Strategy (AAMI)
• Assessing Use-Related Risk: FDA’s New Draft Guidance on URRA (AAMI)
• Senate Bill Illuminates Future of Cyber Enforcement (AAMI)
• No Debating Pennsylvania’s Rejection of Strict Liability for Implantable Medical Devices (Drug & Device Law Blog)
• FDA pulse oximeter guidance unlikely to end years of racial bias
• Fresenius Medical Care increasing IV, dialysis solutions production to alleviate shortages (MedTech Dive)
• Baxter ups IV fluid allocations amid supply shortages (MedTech Dive)
• AHA asks Biden administration for relief amid IV fluid shortage from Hurricane Helene (MedTech Dive)
• The number of AI medical devices has spiked in the past decade (MedTech Dive)
• BD agrees to settle most of its hernia mesh litigation (MedTech Dive)

Global / General Industry News

• Asia-Pacific Roundup: India becomes IMDRF affiliate member (RAPS)
• Transforming Healthcare with Lean Six Sigma (AAMI)

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