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THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

Policy

FDA resumes accepting 510(k)s and De Novos after a 43-day shutdown

MedDevice Startups Staff · Nov 13 · 2 min read · Via HHS FY2026 FDA contingency staffing plan

FDA staff returned on November 13, 2025 and intake of fee-bearing device submissions resumed. From October 1 the agency ran under the HHS contingency plan, which stated FDA could not accept "medical device submissions that require payment of a user fee." That covered new 510(k)s, De Novos and PMAs. Review of submissions already in house continued on MDUFA carryover funds.

Pre-submissions carry no fee, and FDA said acceptance would depend on staffing, but responses slipped anyway. Routine surveillance inspections, sponsor meetings and non-urgent correspondence were deferred for six weeks. For-cause inspections and recall work continued throughout.

A sponsor holding a finished 510(k) on October 1 lost six weeks of calendar before any clock could start. The practical lesson for a startup timing a raise around a clearance is to treat FDA intake as its own risk: pay the fee and upload before an appropriations deadline, because the receipt date is what the MDUFA goal keys on.

Questions & Answers

Did FDA accept new 510(k) submissions during the October 2025 government shutdown?

No. Under the HHS contingency plan FDA could not accept medical device submissions requiring payment of a user fee, including new 510(k)s, De Novos and PMAs, from October 1 until the shutdown ended November 12, 2025.

How long did the 2025 government shutdown last and when did FDA device intake resume?

The shutdown ran 43 days, from October 1 to November 12, 2025. FDA resumed accepting fee-bearing device submissions on November 13, and deferred inspections, meetings and correspondence had to be rescheduled.

Did FDA keep reviewing pending device submissions during the shutdown?

Yes. Review of submissions already received and paid for continued on MDUFA carryover balances. Only intake of new fee-bearing submissions stopped.

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