Pathways’ Pick of the Week: Get Your Global Documents Here

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Keeping track of the constantly evolving rules, guidances, memos, forms, and the array of other documents that make up the landscape of the global medtech regulatory, reimbursement, and policy spheres is a major challenge. MedTech Strategist Market Pathways is launching a new feature to help address it. Here’s a sneak peek at the new Pathways’ Document Depot.

For a complete roundup of medtech policy happenings and documents that should be on your radar this week, and deeper analysis of the sector, check out Market Pathways. The May Pathways’ Document Depot table is here and ongoing updates can be found here. If you don’t subscribe, sign up for a free trial.

In May, China’s National Medical Products Administration drafted technical considerations for assessing human factors in medical devices, the International Medical Device Regulators Forum and the US-based Medical Device Innovation Consortium both weighed in on in vitro diagnostics, and the Centers for Medicare and Medicaid Services issued its draft hospital inpatient rule with important medtech proposals. 

Those were just a few of the important medtech policy documents released last month that are captured in Market Pathways’ newly launched “Pathways’ Document Depot”—a monthly running inventory of global medtech regulatory and policy official documents.   

The full May version of the sortable and searchable tool, with links to the original documents, is now up (and free to view) at the Market Pathways website. Going forward, at Market Pathways, the Document Depot will provide running updates throughout each month on new draft and final guidance document (as well as guidance updates, which are more common as regulatory authorities readjust policies in response to COVID-19), proposed and final rules and regulations, recommendation statements, memos, and much more from national agencies, as well as non-governmental groups and trade associations, and global entities like IMDRF and the World Health Organization.

The feature is focused on policy-setting documents for industry; it intentionally excludes items addressing individual companies, like regulatory approval letters or warning letters (both of which are listed in Market Pathways’ monthly “FDA Output” series).

The goal is to provide a reference source for those working in the medtech regulatory and policy world—a global catalog of the current thinking in the space. And Market Pathways will also report in more detail on some of the most important documents captured each month.

Some noteworthy documents on the May list:

  • Human factors in China: Making products that are technically safe and effective, but also unlikely to be handled incorrectly and unsafely by the user is a special skill and particular challenge of the device industry, and it’s been a topic of growing focus by regulators. China’s agency jumped into the fray last month with detailed “guiding principles” (link in Chinese) on how device manufacturers should consider human factors principles when preparing for technical review by the NMPA. The document is in draft stage and it ultimately will be a non-binding guidance, the agency makes clear. But it offers insights on key human factors concepts like formative and summative evaluation, user-interface considerations, and the role of clinical trials.
  • IVD insights: Diagnostic tests are attracting massive global attention and scrutiny in the context of COVID-19, raising the prospect for governments to reconsider some of their diagnostic policies in the wake of the pandemic. Two draft documents issued last month that are not directly connected to COVID-19 could be important influences, nonetheless, in future IVD reform efforts. The first is a consultation document from IMDRF laying out proposed harmonized principles for risk-classifying IVDs. IMDRF documents are increasingly influential on national policies, particularly as the pandemic experience offers a potential catalyst to accelerate harmonization efforts. The second is a draft framework from MDIC, the public-private partnership co-founded by FDA, on the use of real-world evidence (RWE) to support regulatory decision-making for IVDs. RWE is growing in its prevalence in the device sector, but MDIC points out there is less experience with its use for IVDs—a gap it is looking to fill.
  • New-tech payments: The Medicare agency’s annual rulemaking efforts are important to monitor, and CMS’ hospital inpatient payment rule is, in particular one to watch, due to its impact on many device-intensive surgical procedures. Just about everything that is not a direct response to COVID-19 is overshadowed right now, and the agency was explicit that it was minimizing system changes that aren’t related to the pandemic, but the fiscal year 2021 inpatient proposal is worth a look, in part because it is the first year CMS is applying a new streamlined new-technology add-on payment policy for FDA-designated Breakthrough Devices. At least two devices look primed to leverage the new route, as Market Pathways recently wrote.

Those are only a few of several dozen documents captured in Pathways’ Document Depot. I hope you check it out.

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