RQM+ Weekly Watch #33

RQM+ Recap

RQM+ news, recent content, and upcoming events.

[Next Week] Critical Shifts In Biological Evaluation Panel ??

[November 21] Master the new ISO 14971 framework application to biological evaluation, understand critical updates to device categorization, and learn implementation strategies for maintaining compliance in our Jordi Labs, an RQM+ Company-focused panel discussion on 21 November. Director of Biological Evaluation Taryn Meade leads our esteemed panel, which also includes Stephen Bond, Amanda DeGraw, MS, PhD, DABT, and moderator, Christine Santagate, RAC. We hope to see you in a little over one week!

?? Learn more and join live ???

In-Person Events

See the complete list here. ??

Featured Event ? If you want to learn about the newest developments for regulatory, clinical evidence, and market access - and to discuss these topics in-person with some of the utmost experts in the field – Horizon 2024 is fast approaching. Amie Smirthwaite, PhD, FRAPS is chairing the 20-21 November conference in Copenhagen and has brought together highly experienced experts from notified bodies, industry, and consulting. Attendees will experience a fully-packed and interactive program (nine sessions) over two days and nine sessions.

Europe

• The European Commission released the latest survey data on Notified Body applications and certifications under the MDR and IVDR. There are no new headlines to report from this data: a significant number of Notified Bodies still say that <50% of submissions are deemed to be complete at the point of submission; the bulk of certifications are talking 13-18 months; and again a significant number of Notified Bodies report that >50% of that certification is time where the submission is with the device manufacturer themselves (e.g. compiling a response or providing requested information) rather than with the Notified Body.
• MedTech Europe were co-signatories on a statement regarding the EU's Corporate Sustainability Due Diligence Directive (CS3D). the statement calls for 3 actions to be prioritised:
• The HPRA published the outcome of their public consultation on fees; with no significant comments received the HPRA will be moving forward with their planned changes to fees for HPRA services relating to human medicines, medical devices and veterinary medicines.
• AEMPS have launched a new application for the electronic submission of the communication of the start of the manufacturing activity of medical devices in hospitals for their exclusive use in the hospital itself.
• Innovate UK announced that they have opened a round of further funding (￡8m) for small and medium sized businesses to help them deliver net zero products and services.

United States and Canada

• The FDA have updated their page for the Breakthrough Devices Program, to include data on the number of designations granted in the fiscal year 2024 (ending 30th September 2024). A total of 116 devices have been granted breakthrough designation in the fiscal year 2024.
• The FDA have updated their summary of the reclassification process and list of reclassifications (since 2013).

Rest of World

• Nothing of note.

Recalls, FSCAs, and Alerts

Class I Recall (United States)

• None.

FDA Safety Communications

• Evaluation of Airborne Chemicals from Neonatal Incubators - Letter to Health Care Providers (Updated)

Other FSCAs / Safety Notices

• McGrath MAC Video Laryngoscope - Priority 1 - For Immediate Action - UPDATE (HPRA)
• FSNs published in the UK: Field Safety Notices: 28 October to 1 November 2024

In the News

• Medtronic settles pulse oximetry lawsuit alleging inaccuracies.

Warning Letters (United States)

• Rolence Ent. Inc. MARCS-CMS 695010 — October 18, 2024 [Design Control; CAPA; Complaint handling; Identification/Acceptance; Computer Software Validation; Labelling; Production Control; MDR]
• Micro-X Ltd. MARCS-CMS 692084 — September 10, 2024 [Design Control; CAPA; Complaint handling; Corrections & Removals]
• In the news:Nothing of note.

Approvals, Clearances, and Classifications

De Novo Decision Summaries (Updated):

• DEN220024 - ScanNav Anatomy Peripheral Nerve Block
• DEN210037 - SoClean?3+ Bacterial Reduction Device
• DEN230046 - PGDx elio? plasma focus Dx
• DEN230067 - Germitee Chronos?
• DEN230069 - Mi-CHORD System
• DEN230090 - First To Know Syphilis Test

In the News:

• J&J MedTech Wins FDA Approval For Varipulse Pulsed Field Ablation Platform To Treat Afib
• Advisory Panel Recommends FDA Approve Marketing Authorization For Novel Breast Cancer Treatment.
• J&J wins FDA approval for Varipulse PFA system
• FDA approves J&J’s Varipulse pulsed field ablation system
• FDA clears first treatment for dry AMD, with LumiThera's Valeda
• FDA clears iRhythm’s second 510(k) in response to warning letter
• Distalmotion grabs de novo for Dexter robot in hernia repair

Articles We Read

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

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Europe Related

• Euro Roundup: Council’s adoption of wastewater rules triggers backlash from pharma industry (RAPS)
• Experts: Notified body survey shows MDR/IVDR progress despite some snags (RAPS)
• EU Guidance Details Regulatory Status of Ethylene Oxide (MedTech Insight)
• UK Diagnostic Services Must Get In Shape To Benefit From AI Opportunities (MedTech Insight)
• UK MHRA Plans Revised Device Roadmap By End Of 2024 (MedTech Insight)
• Medtechs Applaud UK Life Sciences Fund But Seek Lowering Of ￡8M Project Threshold (MedTech Insight)
• Medical Device Regulation & In Vitro Device Regulation – Article 10a implementation – EU Commission Q&A published (MedTech Europe)
• "AI ACT": WHAT REQUIREMENTS AND DEADLINES FOR MEDICAL DEVICES? (GMED)
• EU posts guidance on ethylene oxide in device sterilization

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United States and Canada Related

• This Week at FDA: A second Trump term, RFK Jr., and what’s to come (RAPS)
• Recon: How Trump and RFK Jr. could reshape healthcare; Moderna reports slower RSV vaccine sales but better-than-expected COVID vaccine revenue (RAPS)
• Cover Supplemental Breast Screenings, AdvaMed Urges Medicare (MedTech Insight)
• Trump’s Victory Could Bring Kennedy ‘Wild’ Card To FDA (MedTech Insight)
• California District Court Punts on Learned Intermediary Causation Post-Himes (Drug & Device Law Blog)
• Failure-to-Warn Claim Implicating Class II Medical Device that Received De Novo Classification Held Expressly Preempted on Facts Presented ?(Drug & Device Law Blog)
• Unpacking Averages: CDRH Recognition of Consensus Standards Appears to Overlook Software (Health Law Advisor blog)
• To 513(g) or not to 513(g)? That is the question (FDA Law blog)
• Who You Gonna Email? Digital Health Question Busters! ?(FDA Law blog)
• Using Brain Science, AAMI Will Change How Manufacturers Understand Standards (AAMI)
• With Trump victorious, biotech industry’s focus turns to his plans for FDA, FTC
• Advamed asks CMS to cover extra imaging of dense breast tissue
• Medtronic, Recor win CMS transitional payment coverage for renal denervation devices
• Michelle Tarver faces challenges as new CDRH leader. But patient groups, industry are optimistic.
• CMS to pay for renal denervation from Medtronic, Recor Medical

Global Items / General Industry News

• Edwards, Medtronic and Inari share trial data at TCT conference

Stay In the Know

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