Welcome to the July 10 edition of ‘Pathways Picks’, our MTS Market Pathways’ weekly roundup of the most important global medtech regulatory, reimbursement, and policy news. This week: Elizabeth Warren watches the device space, China pilots UDI, another notified body bows out and more. Download a copy of the first issue of Market Pathways and look for updates here.
Watching Warren. Massachusetts Senator Elizabeth Warren is now one of the leading Democratic presidential candidates, so when she criticizes FDA device oversight it’s worth paying attention. Warren did just that in a June 24 letter, also signed by Sen. Patty Murray (D-Wash.), to FDA Acting Commissioner Ned Sharpless and CDRH Director Jeff Shuren scrutinizing a provision in the Trump administration’s latest budget proposal for a two-step “progressive approval” program for devices, in which certain products that address unmet needs could enter the market based on a reduced “safety and performance” standard and “could remain on the market after an established time period only after a demonstration of reasonable assurance of safety and effectiveness.” Warren and Murry asked for the officials to respond to questions on the proposal by July 8. FDA planned to respond directly to the senators. The Senators call the proposal “particularly alarming, given the FDA's already-lenient regulatory framework guiding medical device approval standards.”
UL won’t sell. Another major notified body is (mostly) dropping out of the device space, this time due to the UK’s planned departure from the EU. UK-based UL International said July 3 that, because it would lose its EU designation under the Medical Device Directives under a “no-deal” Brexit, it will cease operations under the MDD (and drop most of its activities under the IVD Directives) beginning Sept. 1. Instead, it has transferred 80% of its CE Certificates to a Polish-based notified body it is partnering with (and the remainder have transferred to another, unidentified notified body). The transfers are helpful to its current clients, but the step means there will be one less experienced notified body available under the oncoming Medical Device Regulation (which takes effect next May). Meanwhile, the status of the Polish notified body, Polskie Centrum Badan, in seeking designation under the MDR is unknown. This, of course, is just the latest reason to worry about MDR implementation. Look for more context on the EU regulations implementation in the July issue of MedTech Strategist Market Pathways.
China UDI. Unique device identification is sweeping the globe, and now China, after years of consideration, is taking a clear step forward on UDI. China’s National Medical Products Administration is launching a UDI pilot project this month focusing on high-risk implantable devices. The goal is to help form the basis of a UDI platform that can be used to track devices to support recalls and adverse event reporting, and as a tool to support reimbursement and data-collection needs., NMPA says. The agency plans to conduct the pilot over the next year and hold a pilot summary meeting next July. International device stakeholders will be watching to see if the China platform harmonizes with the existing FDA UDI system and the pending EU program.
More to Watch
CRT check. On July 5 the US Agency for Healthcare Research and Quality posted a draft technology assessment on cardiac resynchronization therapy favoring CRT with defibrillator and seeking more research in using CRT for patients whose hearts are more functional (ejection fraction between 36% and 50%) than those included in current Medicare coverage policies. It could inform a future Medicare coverage policy update.
Secrets at Supreme Court. The US Supreme Court recently handed down a ruling in Food Marketing Institute v. Argus Leader Media that will make it harder for federal agencies to release companies’ proprietary information to the public. FDA has traditionally considered whether releasing the information will cause harm to the company as the standard, but the case lowers that threshold. “The importance of this decision to FDA-regulated entities cannot be overstated” Hyman, Phelps & McNamara attorneys Anne Walsh and Ricardo Carvajal wrote in the FDA Law Blog. “Now, an FDA-regulated company that is required to submit commercial or financial information to FDA only needs to show its efforts to keep the information private.”
Tennessee tackles law-firm ads. A new Tennessee state law took effect July 1 that establishes significant restrictions and penalties around law firms running advertisements or other communications that mimic “medical alert” notifications to recruit plaintiffs in lawsuits against device and drug manufacturers. The statute, enacted in April, seeks to address the type of arrangement detailed in a 2018 New York Times article, where plaintiff’s law firms linked up with marketing companies and surgeons to spotlight surgical mesh risks, inducing women to have the devices removed to improve lawsuit prospects. Texas recently enacted a similar law that will take effect in September, according to Chris White, AdvaMed’s general counsel.
Brazil steps up in sterilization. The country’s regulatory agency ANVISA blessed the time- and resource-saving parametric release approach for ensuring medical device sterilization, aligning with other global regulators. Traditional sterility testing requires a two-week or more incubation period, while parametric release, which relies on documenting critical process parameters, does not require a wait. ANVISA will also accept assessment with biological indicators.
Cyber focus. FDA has scheduled a meeting of its Patient Engagement Advisory Committee Sept. 10 to discuss best practices for communicating device cybersecurity risks to patients. The meeting notice comes as FDA has stepped up efforts in recent years, with other agencies, to address the threat of hackers, and a week after Medtronic plc issued an alert, followed by an FDA warning, that some of its insulin pumps are susceptible to hacking, based on findings from external researchers. Health Canada, meanwhile, finalized guidance on pre-market cybersecurity requirements June 26.
FDA appeals. A rule finalized July 2 formalizes the process and timelines for appeals, or “supervisory reviews,” of FDA device-center decisions based on reforms enacted by Congress over the past seven years. It distinguishes a process for appealing the fundamental up or down decisions on 510(k)s, PMAs, breakthrough requests and other regulatory submissions (“517A decisions”), and more sub-process decisions by the agency.
Canada tightens hospital reporting requirements. Hospitals will be required to report device and drug adverse events that lead to death, serious injury, or could do so to Health Canada within 30 days of documentation starting Dec. 16 under a new regulation. That is a stricter requirement than in the US, where hospitals and other user facilities must report device-related deaths to FDA and serious injuries to manufacturers but are not required to report malfunctions that might lead to such outcomes if they recur.
Dates To Remember
July 17: A listening session on device interoperability will be held at FDA headquarters and sponsored by the interagency Networking and Information Technology Research and Development (NITRD) program.
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Further Reading in MedTech Strategist Market Pathways:
“EUMDR: Welcome to the New Reality,” by Stephen Levin
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