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De Novo Costs and FDA User Fees: Budgeting Smart

De Novo User Fees, Waivers, and Total Cost Planning

Planning a De Novo submission? Account for FDA user fees, device testing, clinical studies, and regulatory writing in your budget. Check annual MDUFA rates and small business waivers early to protect cash flow and avoid costly surprises during review.

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Beyond testing and consulting, it is essential to factor in the FDA user fee for a De Novo request. The FDA annually publishes fee rates by fiscal year under the Medical Device User Fee Amendments (MDUFA). Small businesses may qualify for reduced rates or first-submission waivers in certain programs; however, rules vary by submission type. Always confirm the current year’s fee rates before filing your request.

Key Budget Line Items for De Novo Submissions

  • Device testing, including bench testing, biocompatibility, software validation, electromagnetic compatibility (EMC), and human factors engineering (HFE), as applicable
  • Clinical study execution, if required
  • Regulatory writing and assembly of the electronic submission using FDA’s eSTAR template
  • Contingency funds for iterative FDA interactions and potential additional data requests

Justifying any omissions in your submission isChecking fees and any small business opportunities early in your planning process helps protect your project runway and avoid unexpected costs. required to meet FDA expectations.

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