ARTICLE SUMMARY:
In this week’s roundup: Possible action to ease pressure from the May 2022 IVD Regulation deadline coming, Biden to rescind Trump guidance policies, FDA upclassifies surgical staplers, Germany reports on digital health reimbursement reviews, Mexico appoints a new commission head, and more from the US, Europe and around the world.
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What we’re watching for:
[Update: The European Commission proposed to expand and extend the IVDR grace period on October 14, the day after this was published.]
Modified IVDR. Device industry and notified body groups have been ramping up calls for EU policymakers to do something to avoid a massive disruption when the IVD Regulation takes effect next May, arguing that big product shortages will result if nothing changes. We are looking for action in response to those calls in the coming weeks. The European Parliament will hold its next full session from October 18-21 and the European Council convenes next on October 21-22, providing opportunities to consider statutory reforms to IVDR to relieve the pressure.
An outright postponement of the May 26 go-live date is not expected, but it is more likely that lawmakers could take the step of extending an IVDR grace period to more tests. Upward of 80% of IVDs have been able to self-declare under the legacy IVD Directive (IVDD). But most of those tests require notified body assessments for the first time under IVDR, leading to a likely bottleneck with only six notified bodies currently designated under the new rules. Currently, only tests with a prior notified body-assessed certificate can take advantage of the grace period that allows an IVDD certificate to stay active to 2024. Lawmakers may decide to allow all or some portion of self-declared tests to take advantage of the grace period. They took a similar action in the months leading up to the Medical Device Regulation (before ultimately postponing the MDR for a year due to COVID-19). The EU legislative bodies may not finalize any reforms at the upcoming sessions, but policymakers have suggested some direct action will be taken in October.
Rescinding Trump guidance rule. In the coming days or weeks, HHS may rescind a “Good Guidance Practices” regulation that was finalized at the tail end of the Trump administration to add more controls around the release and application of guidance documents. The Biden administration’s HHS has been working on a proposed rule entitled “Streamlining HHS Guidance Practices” in recent months and it now appears the Office of Management and Budget has completed vetting of the document, suggesting an imminent release. A brief OMB description of the pending rule says HHS “proposed to rescind its regulations governing the agency release and maintenance of guidance documents.” The Trump rule did not have a significant impact on FDA guidance practices, as the agency already had somewhat similar practices in place. The expected action, however, underscores the longstanding tension between guidance documents as a tool for efficient policy dissemination versus charges that agencies too often use guidances when they should be pursuing rulemaking to enact new policies.
