RQM+ Weekly Watch #9

RQM+ Recap

RQM+ content published last week and upcoming online events.

Technical Briefs

• None last week.

Video/Audio

• FDA Releases Final Rule on Laboratory-Developed Tests (LDTs): What You Need to Know | MedTech Voices | LinkedIn, Apple Podcasts, Spotify
• Excellence Spotlight Interview: Samantha Howard , Study Director ( Jordi Labs, an RQM+ Company , an RQM+ Company) | LinkedIn, Apple Podcasts, Spotify

Upcoming

• [RQM+ Live! #79] 6 June panel and Q&A – FDA's Wound Care Shakeup: Ensuring Your Products Make the Cut

Europe

• The European Commission has opened a consultation to collect information on the functioning of Regulation 1025/2012 (on European standardisation). One of the aims of the consultation is to determine whether any of the key parties and stakeholders can identify any shortcomings in the existing legislation or opportunities for the future development of the European standardisation system.
• Oliver Bisazza of MedTech Europe published a blog titled Over the Finish Line: Recent EU Policy Milestones Impacting Healthcare.?
• The MHRA published a report on titled “Impact of AI on the regulation of medical products - Implementing the AI White Paper principles”
• The MHRA have updated their guidance on software and artificial intelligence as a medical device with an update to the section on digital mental health technology.
• The MHRA also released their latest blog: April MedTech regulatory reform update: international recognition, IVDs and AI

United States and Canada

• The FDA have published the final rule for Laboratory Developed Tests (LDT) in the federal register. This rule will be effective as of 5th July 2024. Here is the FDA's official announcement, summary and FAQ. Others have covered this publication:
• — The Association for Diagnostics & Laboratory Medicine (ADLM) released an overview of the FDA's final rule on laboratory developed tests (LDT).
• — Diagnostics World provided their own review titled Unpacking the New FDA LDT Rule.
• — RQM+'s Bethany Knorr Chung, PhD, RAC and Margot Borgel, Ph.D. dive into the details of what you need to know, including: the 4-year phase-in timeline for compliance; the expanded enforcement discretion for certain LDTs; the grandfathering clause for currently marketed LDTs.
• Also on the topic of IVDs, the FDA published two draft guidance documents on the Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564. and on the Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency.
• The FDA have added Apples Atrial Fibrillation History Feature to their list of Medical Device Development Tools (MDDT). The Atrial Fibrillation (AFib) History Feature is an FDA-cleared (K213971), commercially available over-the counter (“OTC”) software-only mobile medical application intended for users 22 years of age and over who have a diagnosis of AFib. The Apple AFib History Feature can be used as a biomarker test to help evaluate estimates of AFib burden as a secondary effectiveness endpoint within clinical studies intended to evaluate the safety and effectiveness of cardiac ablation devices.?

Rest of World

• The IMDRF have published a whitepaper on the topic of Reliance, as an output of the recent workshop as part of the 25th meeting, held in Washington.
• The IMDRF have updated a number of guidance documents, including “Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices” and ”Principles of Labelling for Medical Devices and IVD Medical Devices".
• The TGA have updated their own guidance for the in-house manufacture of IVDs.

Recalls, FSCAs & Alerts

Class I Recall (US)

• BioMérieux Inc. Recalls VITEK 2 AST Kit due to Incorrect Ceftriaxone Concentrations
• SonarMed Inc. Recalls Airway Acoustic Sensors Due to a Restricted Inner Diameter of Airway Causing Suction Catheter Passage Difficulty
• SonarMed Inc. Recalls Airway Monitors Due to a Software Anomaly Resulting in Failure to Detect a Partial Obstruction in 2.5mm Sensors and Up To 3mm Distal to the Sensor Tip
• Elekta Instrument AB Recalls Disposable Biopsy Needle Kit for Leksell Stereotactic System for Possibly Containing Microscopic Stainless Steel Debris on the Inside of the Biopsy Needle?

FDA Safety Communications

• None of note this week.

Other FSCAs / Safety Notices

• FSNs published in the UK: Field Safety Notices: 22 to 26 April 2024

In the News

• FDA warning letters highlight CAPA concerns (European Pharmaceutical Review)
• Cardinal receives FDA warning letter over unapproved syringes
• Philips reaches major settlements related to respiratory devices recall
• Philips agrees to $1.1B settlement of US respiratory recall lawsuits
• Judge approves settlement of more than $500M from Philips recall
• Fresenius Medical Care recalls 2M dialysis devices over toxin exposure risk
• Infutronix infusion pump recall linked to 6 injuries, 1 death

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Warning Letters (US)

• P.T. Sankei Medical Industries MARCS-CMS 665754 — SEPTEMBER 19, 2023 [Misbranding, DMR, DHR, Complaints, Design Control, Internal Audits, MDR]
• Spectrum Medical Ltd MARCS-CMS 666543 — SEPTEMBER 29, 2023 [Misbranding, CAPA, control of nonconforming product]
• Future Diagnostics Solutions B.V. MARCS-CMS 653493 — MAY 11, 2023 [CAPA, control of nonconforming product, Internal audits, MDR, Statistical techniques]
• Pinnacle Labs of Tennessee, LLC dba Pinnacle BioLabs MARCS-CMS 676367 — APRIL 17, 2024 [Misbranding, complaints, MDR, CAPA, Design Control] ?

Approvals and Clearances

• Consumer Information: XACT Carotid Stent System - P040038/S043 (Abbott Vascular Inc.)
• Consumer Information: Paradise Ultrasound Renal Denervation System - P220023 (Recor Medical, Inc.)
• Consumer Information: FoundationOne CDx Liquid (F1 Liquid CDx) - P190032/S011 (Foundation Medicine, Inc.)

Articles We Read

Europe Related

• UK sets out position on regulating AI as a medical device
• EU Regulatory Roundup, April 2024: EU On Cusp Of Regulatory Shifts Amidst Political Change (MedTech Insight)

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United States Related

• OMB Completes its Review of the Final LDT Rule—A Final Rule Coming Anytime Now (FDA Law Blog)
• It’s Official: FDA Drops Final Rule On LDTs (MedTech Insight)
• LDT Final Rule: Shifting the LDT Battlefield (King & Spalding)
• Lab test overhaul: FDA to regulate LDTs as medical devices
• The End* of a Long and Winding Road: FDA Publishes Final LDT Rule (*Or Is It?) (FDA Law Blog)
• FDA defends LDT final rule, while critics fear it upends lab industry
• FDA finalizes lab developed test rule despite industry opposition
• It’s Been a Long Time Coming – FDA’s Final Rule on Regulation of Laboratory Developed Tests (LDTs) as Medical Devices Has Arrived
• ICER Debuts Clinical Trial Diversity Assessment Framework (MedTech Insight)
• FDA’s Draft Guidance on the Q-Submission Program – A Step in the Wrong Direction
• FDA qualifies Apple Watch’s AFib history for use in clinical studies
• Apple Watch’s AFib detection tool earns landmark FDA approval
• Senseonics gets FDA clearance to pair CGM implant with insulin pumps
• Labcorp gains FDA approval for companion diagnostic to Pfizer gene therapy
• Abbott wins FDA approval for Esprit resorbable scaffold
• Medtronic wins FDA approval for Inceptiv closed-loop spinal cord stimulator
• HHS Extends the Antidiscrimination Provisions of the Affordable Care Act to Patient Care Decision Support Tools, Including Algorithms
• FDA officials: Consider a master validation plan for process validation during inspections (RAPS)
• MedCon: FDA readies staff, device makers for QMSR (RAPS)?
• MedCon: CRDH official offers tips for electronic submissions, eSTAR technical screening (RAPS)
• FDA issues long-awaited LDT final rule (RAPS)
• Stakeholders push for greater inclusion in FDA’s race and ethnicity data collection guidance (RAPS)
• M.D. Alabama Holds that Comment k Can Apply to Medical Devices (Drug and Device Law blog)
• Hip Implant Remand Case Mails It In On Expert Motions (Drug and Device Law blog)
• Frequent Flier P-Side Expert Excluded Under Amended Rule 702 (Drug and Device Law blog)
• A New Version of the One-Two Punch: Standing and Preemption (Drug and Device Law blog)

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General Industry News

• New Report Showcases a Global Regulatory Affairs Workforce of Nearly 125,000 Professionals Across the Healthcare Products Sector (RAPS)

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