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Key Content and Format for a Successful De Novo Request

What to Include in a De Novo (and How to Format It)

De Novo requests under 21 CFR 860.220 must include device details, labeling, testing, risk mitigations, and proposed controls. FDA’s eSTAR template streamlines submission, reduces errors, and links risks to objective evidence.

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← Back to De Novo Classification Requests

The content of a De Novo submission is defined in 21 CFR 860.220 and includes the following key elements:

  • Table of contents
  • Administrative information
  • Device description
  • Indications and contraindications
  • Labeling
  • Applicable standards
  • Software and cybersecurity (as applicable)
  • Verification and validation data
  • Clinical data (if needed)
  • Benefit-risk analysis
  • Proposed special controls
  • And more

Justifying any omissions in your submission is required to meet FDA expectations.

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Formatting Your De Novo Submission

Format matters. FDA’s Electronic Submission Template And Resource (eSTAR) guidance for De Novo (updated August 2024) details how to structure and electronically transmit your request to CDRH/CBER. Using eSTAR reduces formatting errors and speeds intake, improving your submission’s efficiency.

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Risk Mitigation and Evidence

Tie each identified risk to a mitigation strategy and provide supporting evidence. If proposing special controls, ensure they are:

  • Objective
  • Testable
  • Enforceable

Reference applicable consensus standards where relevant to strengthen your submission.

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Checklist Highlights for De Novo Submissions

  • Labeling aligned to indications and risk mitigations
  • Biocompatibility, shelf life, sterilization, electromagnetic compatibility (EMC), software, usability, and human factors as applicable—each mapped to identified risks
  • Clinical data acceptance criteria, including assurance of Good Clinical Practice (GCP) compliance and data integrity where clinical evidence is needed
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