Navigating the Government Shutdown: An Update for MedTech Impact Partners
A potential government shutdown introduces immediate shifts in the FDA's regulatory cadence for the MedTech industry. Our primary goal at MedTech Impact Partners is to navigate these circumstances with minimal disruption to your critical work and active FDA submissions.
Here is a concise breakdown of what you need to know and how we are advising our partners:
FDA Operations: What to Expect
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A core team of senior FDA management will continue to work. They will manage files based on risk assessment, prioritizing the most critical public health projects.
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Anticipate delays. Due to reduced staffing, non-critical review work may slow down or pause. Your MedTech Impact Partners team will reassess and adjust specific project timeline estimates with you.
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We expect post-market inspections to be significantly paused or slowed, though essential inspections (imminent public health threats) may continue.
Our Communication & Monitoring Protocol
Proactive communication is paramount. We recommend the following to ensure you get the most reliable, real-time information:
Direct Inquiries: Do not rely on general FDA lines. For urgent questions regarding specific files, email your Office Director.
Monitor Actively: The CDRH Portal will be the most reliable source for real-time status updates on your premarket submissions. Check it daily.
We are closely monitoring the situation and will provide further updates as they become available. Please reach out to your primary MedTech Impact Partners contact directly if you have any questions about your specific 510(k) De Novo, PMA, or clinical work.
About the MedTech Impact Partners
MedTech Impact Partners (MIP) is a regulatory strategy consulting firm leveraging executive-level FDA and MedTech operational experience to deliver tailored solutions that create company value.