ARTICLE SUMMARY:
In this week’s roundup: Looking out for agreements on EU IVDR revisions, US government funding and user fees; 510(k) reform talk; eSTAR expansion; EUDAMED rules; notified body #25; China addresses submission quality, companion diagnostics, and more to watch.
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What we’re watching for:
IVDR relief approval. The EU Council, which represent member state leaders, is set to approve a proposal to expand and extend grace periods under the IVD Regulation that was issued by the European Commission in October. The Council will address the matter via an accelerated process during its upcoming December 6-7 session, according to a backgrounder document posted today. That puts attention to the Parliament, which is the other EU legislative body that must approve the plan for it to take effect before the IVDR fully applies on May 26, 2022. The Parliamentary committee with oversight on the issue has taken an initial look at the proposal but has yet to move forward on it, according to Erik Vollebregt, an EU medical device attorney. The Commission's plan would benefit tests that are currently on the market via a self-certification process under the legacy IVD Directive but that will require a notified body assessment under the IVDR. That is upwards of 20,000 tests that could remain on the market with their current certification for an extra three-to-five years, depending on risk category.
US government funding? Congress has until midnight Friday to reach a deal on a short-term funding bill to avoid a government shutdown. We anticipate a last-minute agreement to maintain funding for federal agencies including FDA, but extreme political polarization over issues including vaccine mandates makes that prediction tenuous. Threats of shutdowns have become increasingly common. As reported in September, when the government last was at the brink of a potential funding lapse, FDA would have to temporarily furlough about 30% of its staff who are not funded by user fees and not considered “vital.” Any agreement reached this week will likely fund the government until March at the latest, and potentially just until January.
A user fee deal? The other deal we are looking for soon, though probably not by the end of this week, is one between FDA and industry on MDUFA V user fee reauthorization. The two sides have engaged in challenging negotiations since February, presenting very different visions for the size and breadth of the next user fee program. But Market Pathways reported in October that negotiators were coming closer to alignment. The statute requires FDA to send a final agreement to Congress by January 15 so it can start the legislative process for reauthorization, and the agency is supposed to present the deal in a public meeting in advance of that date. Particularly with December holidays, time is running out. While in previous user fee negotiation cycles, FDA was relatively consistent about issuing “meeting minutes” summarizing negotiation sessions, the agency has not posted MDUFA V negotiation minutes since April. The only source of information on the progress of the closed-door negotiations has been reporting from Market Pathways and several other media outlets.
