ARTICLE SUMMARY:
We track government shutdown worries and agency actions as the current fiscal year winds down. Excerpted from Pathways’ Picks September 13: End-of-FY Action, FDA Docs, and Global Updates
Autumn approaches and fears of a government shutdown are in the air. It’s become an annual reality, and the risks of Congress not reaching a funding deal by the end of the fiscal year (September 30) are as high as ever as House Republican leadership gets further embroiled in intra-party battles over slashing budgets and investigating the president. FDA, CMS, and other federal agencies are operating as normal under FY 2023 budgets, although the lack of any funding agreement at this stage adds uncertainty to staff planning (e.g., travel and other staff operation budgets can’t be finalized). In the event of a government shutdown (which can last as short as a few hours but in one instance stretched for more than a month), MDUFA user fee-funded device reviews can continue, but many other activities are halted and non-fee-funded staff are furloughed. Shutdown risks also tend to hobble FDA’s recruitment efforts, as the agency tries to make a major hiring push under MDUFA V. The realistic alternative to a shutdown in the near-term is a short-term continuing resolution that funds agencies at FY 2023 levels for several weeks or months as lawmakers try to work out a longer -term package.
CDRH watch.The end of a fiscal year always drives an uptick in guidance and other policy outputs from FDA as the agency tries meet annual priorities and clear the deck. That extra activity has already been on display with 16 draft and final FDA guidance documents published in the past two weeks (six with CDRH involvement). It’s likely there will be at least a few more items to come over the next two weeks. Perhaps the most highly anticipated item is one that is already out of FDA’s hands: a proposed regulation on an oversight framework for laboratory developed tests that is now held up in HHS- and White House-level politics. Based on previously disclosed center priorities, a few other device items that could be in the mix (though I wouldn’t bet on any one in particular) are:
- Remanufacturing final guidance: A draft version of this document that defines what constitutes regulated “remanufacturing,” rather than unregulated servicing, of devices has been lingering for more than two years.
- Cybersecurity final (or draft) guidance: FDA has held off on enforcing new statutory-level premarket submission cybersecurity requirements, but that enforcement discretion ends October 1. It’s possible the agency will want to finalize its detailed guidance on premarket expectations (issued as a draft in 2022) in conjunction with that shift. Although, FDA may need to issue the document as a revised draft-for-comment to reflect the legal requirements enacted by Congress in last December’s omnibus package.
- De Novo eSTAR draft guidance: FDA is rapidly building out use of its electronic Submission Template and Resource (eSTAR) and as part of that effort it has been working on draft guidance to support use of the standardized template for De Novo submissions. Meanwhile, beginning October 1, all 510(k)s, unless exempted, must be submitted to FDA via eSTAR.