Pathways’ Picks February 19: Coronavirus Cancellations, EU Digital, NICE on Neurostim

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The International Medical Device Regulators Forum cancelled its March meetings in Singapore due to the novel coronavirus, Europe issued a digital plan, and the UK’s closely watched health technology assessment body showed support for a neuromodulation therapy for overactive bladder. That and more in this week’s Pathways’ Picks, Market Pathways’ weekly roundup of the most important global medtech regulatory, reimbursement, and policy news.

Global regulators cancel meetings and inspections in the wake of the novel coronavirus. A new notified body, UK NICE recommendations, Australia review timeframes, and more in this week’s Pathways’ Picks.

Top Picks

Coronavirus cancellations. Global regulatory activities are not business as usual amid the persisting coronavirus outbreak. That was underscored this week in the medtech space with the decision by the International Medical Device Regulators Forum to cancel its upcoming meetings in Singapore. The sessions were not scheduled to take place until mid-March, but IMDRF says it decided to cancel “in view of the evolving circumstances due to the COVID-19 outbreak.” Singapore has reported more cases of coronavirus than any other country outside of China. The IMDRF announcement followed the latest coronavirus update from FDA, which said last Friday it is working on overdrive to get ahead of any potential product shortages, but at the same time has recalled its staff from China and is currently not conducting any facility inspections in the country.

Europe’s digital plan. The EU released a new data strategy and a white paper outlining its approach to artificial intelligence in all industries, including healthcare, February 19. MedTech Europe says it welcomes the documents “as tools to unleash the potential of data and artificial intelligence in the healthcare sector, with respect to Europe’s values and principles.

NICE note for Axonics. Sacral neuromodulation to treat overactive bladder with Axonics Modulation Technologies’ device got a thumbs-up in a draft review from the UK’s National Institute for Health and Care Excellence February 14. NICE says the rechargeable Axonics SNS device improves symptoms and quality of life and has a longer battery life than other systems. It estimates it would save the National Health Service about£6,200 per person over 15 years compared to non-rechargeable systems. The NICE recommendation comes a little more than a week after Germany granted the Axonics system extra reimbursement to cover hospital costs.

Scoping notified bodies. National Standards Authority of Ireland is the 11th notified body to win designation to operate under the EU Medical Device Regulation, and the first from Ireland. Of note, NSAI was granted MDR designation for 58 out of total of 71 device and process codes—leaving some gaps in coverage relative to its standing under the legacy EU directives. For a closer look at the current state of the scope of designations for MDR notified bodies, check out our recent article, “Scoping Out Notified Bodies: Looking Beyond the MDR Designation Count.”

Agency Updates

Malaysia regs. “Orphaned” medical devices that are no longer supported by a manufacturer or representative are addressed in guidelines issued by Malaysia’s Medical Device Authority February 18. The guidance was developed specifically to assist healthcare facilities to comply with MDA’s notification/listing requirements. On the same day, MDA also circulated a notice stating that, beginning on February 24, device companies can renew already-expired licenses. Companies need to review prior to the expiration date or submit for a new registration.

Australia review times. Australia’s Therapeutic Good Administration released new target timelines for its device and diagnostic review process, based on international benchmarks and typical TGA practice. TGA’s process is split into two parts: a conformity assessment and a process for inclusion of the device in the Australian Register of Therapeutic Goods (ARTG). Similar to FDA goals the timeframes are tiered—for instance, TGA says it will complete 75% of medical device conformity assessments within 220 working days and 95% of them within 238 working days. The goals for inclusion in the ARTG are specific to different device risk classes.

FDA workshops. The US agency recently scheduled two public workshops. On March 31, FDA, with theInternational Society for Pharmacoeconomics and Outcomes Research, will host a meeting at its Maryland headquarters on using patient preference information to inform medical device regulatory decisions. At the same location, in April, FDA will hold a three-day workshop (April 13-15) on the use ofcomputational modeling and simulation in health technologies.

More to Watch

EPA input from Shuren, industry. The director of FDA’s device center Jeff Shuren is urging the Environmental Protection Agency to set appropriate limits on ethylene oxide (EtO) emissions to protect human health, and to let FDA work with device makers and sterilizers to ensure proper device sterilization under those limits. The message comes in a February 5 letter from Shuren, submitted to an EPA docket established to collect feedback that will inform planned EPA regulations on commercial EtO sterilizers. Alarms have been raised in neighborhoods nearby sterilization plants in recent years, in reaction to updated EtO thresholds and air monitoring data in recent years. This has led to state actions and some plant closures, risking shortages of some medical devices. In a February 10 letter, AdvaMed argues that a “uniform emissions factor” should not be used to calculate fugitive emissions across the entire commercial EtO sterilization industry. The Medical Device Manufacturers Association sent its own letter to EPA arguing against an outright ban of EtO sterilization, which some state policymakers have raised.

AdvaMed privacy principles. The device trade group circulated its US Health Data Privacy Principles, underscoring the industry’s support for a national approach to data privacy, as opposed to a state-by-state patchwork of regulation.  

Hospital chain settles with feds on unnecessary implants. Major healthcare system Tenet Healthcare, and one of its affiliated hospitals, agreed to pay $1.41 million to resolve allegations that it violated the False Claims Act by implanting unnecessary loop recorders to monitor heart rhythms, the US Department of Justice announced February 11. No device manufacture was targeted in the suit.

Alzheimer’s agent adcomm. A PET imaging agent intended to help with Alzheimer’s diagnosis will go before an FDA advisory committee April 23. Avid Radiopharmaceuticals/Eli Lilly & Co.’s new drug application for flortaucipir F18 intravenous injection will be reviewed by the agency’s Medical Imaging Drugs Advisory Committee. The imaging agent is intended to help estimate the density and distribution of aggregated tau neurofibrillary tangles of Alzheimer’s disease.

Dates to Remember

February 24. Comments are due on a draft guidance on requesting FDA feedback on combination products.

February 25-26. FDA will hold a workshop on"Evolving Role of Artificial Intelligence in Radiological Imaging." 

February 26.The House Energy and Commerce Health Subcommittee will hold a hearing on the HHS 2021 budget request and its coronavirus response.

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