Medical Device User Fee Rates for Fiscal Year 2027
FDA announced FY2027 medical device user fee rates. The new rates apply to all medical device submissions, including AI/ML-enabled devices. Specific dollar amounts are not provided in the excerpt; refer to the full notice for exact fees.
Aforeworn detected this change in the Healthcare AI Regulation (FDA / ONC) space on July 30, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Medium urgency. Medical device companies, health tech startups, digital health compliance teams submitting devices to FDA in FY2027. should confirm how it applies to their specific situation before acting. There is a time constraint attached: FY2027 begins October 1, 2026. Fees apply to submissions received on or after that date.. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Healthcare AI Regulation (FDA / ONC) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
User fee rates for medical device submissions (e.g., PMA, 510(k), De Novo) for FY2027 are updated. Exact fees must be obtained from the full notice.
Who it affects
Medical device companies, health tech startups, digital health compliance teams submitting devices to FDA in FY2027.
What you must do
Review the new fee schedule and adjust budget and submission plans accordingly for FY2027 submissions.
Deadline
FY2027 begins October 1, 2026. Fees apply to submissions received on or after that date.
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