RQM+ Weekly Watch #26

RQM+ Recap

RQM+ news, recent content, and upcoming events.

MDR/IVDR Amendments Panel Now Available On Demand

[Now On Demand] Last week's panel discussion exploring the implications for manufacturers due to the MDR and IVDR amendments is now available on demand. Panelists included guests Heike Moehlig-Zuttermeister of TüV SüD , Erik Vollebregt of Axon Lawyers, and Donielle Johnson.

?? Watch and listen on demand ??

?? RQM+ at RAPS Convergence In Long Beach, CA This Week

?? Four ways to find us at the Regulatory Affairs Professionals Society (RAPS) Convergence

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16-17 Sept. | 8:30 AM – 4:00 PM PDT

RQM+ VP of MedTech Innovations, Allison Komiyama, PhD, RAC, is one of the instructors. She joins Mark DuVal, J.D. FRAPS, Lisa Pritchard, Kathy Herzog, Dongbo Wang, and FDA/CDRH Deputy Ombudsman, Ken Skodacek.

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Wednesday, 18 Sept. |?8:15 AM – 9:00 AM PDT

Allison Komiyama, PhD, RAC is a panelist, along with Cheryl Coon, Karl-Heinz Huemer, and Justin West, MD. Jo?o Duarte will moderate.

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Wednesday, 18 Sept. | 12:25 PM – 12:50 PM PDT

RQM+ Vice President of Technical, Jonathan Gimbel, will present, and be joined by Fern.ai Product Manager, Sara Contu, MSc.

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If you're attending, please stop by!?We can't wait to meet and catch up with attendees in person. You can enter for a chance to win a ?, too.

Europe

• The European Commission published a report on ‘The future of European competitiveness. Part A: A competitiveness strategy for Europe’.
• Team-NB published a position paper on the transfer of surveillance duties for legacy IVDs: TRANSFER AGREEMENT FOR SURVEILLANCE OF LEGACY DEVICES specifying the terms of the transfer of the appropriate surveillance activities according to ?Article 110 (3e) of Regulation (EU) 2017/7461 in respect of legacy devices covered by a certificate issued in accordance with Directive 98/79/EC.
• Team-NB also published their updated list outlining the status of their position papers. It is worth noting that their best practice guidance for EU MDR Technical Documentation (currently on its 2nd version) is marked as under revision.
• In the UK, the results of an independent investigation of the National Health Service in England has been published.

United States and Canada

• The FDA published final guidance on Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Referring Provider Notification Orders -?Guidance for Mammography Facilities and Food and Drug Administration Staff.
• The FDA have published some recent classification decisions: FDA has classified the whole exome sequencing constituent device as class II (special controls); FDA has classified the pediatric continuous renal replacement therapy system as class II (special controls); FDA has classified the device to detect or measure nucleic acid from viruses associated with head and neck cancers as class II (special controls); and FDA has classified the clozapine test system as class II (special controls).
• The FDA published a press release related to two warning letters. The warning letters were issued to two Chinese nonclinical testing laboratories, citing both for laboratory oversight failures and animal care violations that raise concerns about the quality and integrity of data generated by the labs. The firms provide third-party testing and validation data services to device manufacturers for use in their premarket device submissions to the FDA. The FDA continues to conduct a rigorous review of data generated from these test facilities, submitted in premarket submissions, and does not intend to authorize submissions where the data are necessary for the FDA to make a marketing authorization decision, as such data are found to be unreliable. The agency is evaluating any impact these findings have had on past submissions and will take action to address any public health risks as necessary. Owen Faris, Ph.D., acting director of the Office of Product Evaluation and Quality in the FDA’s Center for Devices and Radiological Health said "We strenuously remind industry of their responsibility and accountability for all data included in their submissions, which are required to comply with federal law.”.
• The FDA's list of recognized consensus standards has been updated with the following standards (from List #063): ISO 11737-3:2023 Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing; ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements; and ISO 13004:2022 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD.

Rest of World

The TGA have opened a consultation to gather feedback on proposals identified for mitigating risks and leveraging opportunities associated with the use of AI models: Clarifying and strengthening the regulation of Artificial Intelligence (AI).

ISO released their monthly list of published standards (01 August - 31 August). Of note for the medtech industry are:

• ISO 10555-8:2024 Intravascular catheters — Sterile and single-use catheters — Part 8: Catheters for extracorporeal blood treatment;?
• ISO 15378:2017/ Amd 1:2024 Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) — Amendment 1: Climate action changes;?
• ISO 6872:2024 Dentistry — Ceramic materials;?
• ISO 19211:2024 Anaesthetic and respiratory equipment — Fire-activated oxygen shut-off devices for use during oxygen therapy;?
• ISO 80601-2-79:2024 Medical electrical equipment — Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment;?
• ISO 80601-2-80:2024 Medical electrical equipment — Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency;?
• ISO 23500-1:2024 Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements;?
• ISO/TS 9320:2024 Health informatics — Standardized data set for transfer of hemodialysis patients; and?
• ISO/IEEE 11073- 10421:2024 Health informatics — Device interoperability — Part 10421: Personal health device communication — Device specialization — Peak expiratory flow monitor (peak flow)

Recalls, FSCAs & Alerts

Class I Recall (US)

• None to report this week

FDA Safety Communications

• Related Recalls - Plastic Syringes Made in China for Potential Device Failures (Updated)

Other FSCAs / Safety Notices

• FSNs published in the UK: Not published yet.

In the News

• ‘Catastrophic’ Risk Linked To Smiths Medical Trach Tubes (MedTech Insight)
• Smiths Medical links 1 death, 35 injuries to defective airway tubes

Warning Letters (United States)

• Sanitation & Environmental Technology Institute dba SDWH MARCS-CMS 687970 — September 10, 2024 [Failings in GLP, 21 CFR 58]
• Mid-Link Testing Company, Ltd MARCS-CMS 687111 — September 10, 2024 [Failings in GLP, 21 CFR 58]
• Optikem International, Inc. MARCS-CMS 683606 — August 13, 2024 [Process validation; Calibration; Design Control; CAPA; Adulteration/Misbranded]
• In the news:FDA warns 2 Chinese labs for oversight failures, animal care violations

Approvals, Clearances, and Classifications

De Novo(s) Decision Summaries Updated:

• DEN220083 - Stanza
• DEN220059 - NTX100 Tonic Motor Activation (NTX100 ToMAc) System
• DEN220027 - B-R-A-H-M-S sFlt-1/PIGF KRYPTOR Test System
• DEN220058 - BT-001
• DEN220041 - TRISTEL DIO ULT
• DEN230036 - Sepsis ImmunoScore
• DEN200052 - KidneyIntelX.dkd

De Novo Reclassification Order?- DEN230090 First To Know Syphilis Test (NOWDiagnostics)

In the news:

• FDA Releases Six More De Novo Summaries
• Apple wins FDA nod for hearing aid software for certain Airpods
• FDA clears OTC hearing aid features for Apple's AirPods
• FDA clears Withings' contactless mat for diagnosing sleep apnea
• Think Surgical collects clearances for knee replacement robot

Articles We Read

Note: We're including some articles that are behind a paywall (MedTech Insight) and will clearly note when that's the case. We recognize some readers subscribe and links are helpful.

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Europe Related

• Opinion: Is The EU Recreating A Different Monster Of A Regulatory Labyrinth? (MedTech Insight)
• ISS Named As Italy’s First Notified Body Under The EU’s IVD Regulation (MedTech Insight)
• Illumina court ruling limits EU regulators’ merger review power (MedTech Dive)
• MedTech Europe’s views on the AI Act (MedTech Europe)
• MedTech Europe Statement: Closing innovation launch gaps in health is key to Europe’s prosperity and competitiveness (MedTech Europe)

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United States Related

• Mammograms Should Inform Women About Breast Density, FDA Says (MedTech Insight)
• Prodded By Congress, FDA Launches Tampon Review (MedTech Insight)
• Lab Association Asks Congress To Kill FDA’s Final Rule On LDTs (MedTech Insight)
• Does SCOTUS Chevron Decision Tip The Scales In Favor Of Industry? (MedTech Insight)
• FDA to investigate presence of metals in tampons (MedTech Dive)
• Lab group urges lawmakers to rescind FDA final rule on LDTs (MedTech Dive)
• Many FDA-authorized AI devices lack validation data (MedTech Dive)
• FDA to test tampons for lead, arsenic and other metals
• Days Go By* – Particularly When Responding to an FDA Inspection (FDA Law Blog)
• FDA Officially Recognizes AAMI Sterilization Standards (AAMI)
• The regulatory? landscape of ingestible medical devices in the United States (RAPS)
• Erie Doctrine Requires Narrow Interpretation of Florida Human Tissue Shield Statute (Drug & Device Law Blog)
• The Intersection of Telehealth, Privacy, and Medical Devices (Drug & Device Law Blog)
• Loper Bright Likely Lays Lohr Low (Drug & Device Law Blog)

General industry news:

• China Moves From Administrative Orders To Medtech Law – Consultation Underway (MedTech Insight)
• The High Cost of Poor Quality (AAMI)

Stay In the Know

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