De Novo Submission: A Pathway for Novel Medical Devices

A De Novo request is submitted to the FDA to establish a new classification for a novel device when:

• No legally marketed predicate exists
   
• The device does not require a full PMA due to its risk level
   
• The device’s risks can be adequately mitigated through general and/or special controls
   

This pathway is especially useful for first-of-a-kind devices that are safe and effective but fall outside existing regulatory categories.

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• When Is a De Novo Appropriate?
• A De Novo submission may be appropriate when:
• A prior 510(k) submission received a “Not Substantially Equivalent” (NSE) determination
   
• Or you are making a Direct De Novo request for a novel device without submitting a 510(k) first
   
•  Benefits of De Novo Classification
• Creates a new Class I or II classification
   
• Allows the new device to be used as a predicate for future 510(k) submissions
   
• Avoids the more complex and costly PMA process
   
• Accelerates market entry for innovative technologies
   
•  How RAPS Can Support Your De Novo Submission
• At RAPS, we guide clients through every stage of the De Novo process:
• Determining eligibility for the De Novo pathway
   
• Compiling required safety, performance, and risk mitigation data
   
• Drafting and submitting the full De Novo request
   
• Managing interactions and follow-ups with the FDA
   
• Bring your innovation to market with confidence.
  Let RAPS help you navigate the De Novo process and secure a new FDA classification for your groundbreaking medical device.

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• Regulatory Pathway for De Novo Submission
• The FDA provides two primary routes for manufacturers to request De Novo classification, both designed to determine whether a novel medical device qualifies as a Class I or Class II product based on risk.
•  De Novo Classification Options
• After a 510(k) Denial (NSE):
  Submit a De Novo request following a “Not Substantially Equivalent” (NSE) determination from the FDA.
   
• Direct De Novo Submission:
  Apply directly through the De Novo pathway without a prior 510(k) when it's clear no suitable predicate device exists.
   
•  When to Use the De Novo Pathway
• Consider De Novo classification when:
• Your device is entirely novel and has no legally marketed predicate
   
• The device presents low to moderate risk (Class I or II)
   
• The risks can be adequately mitigated with general and/or special controls
   
• The device would otherwise be classified as Class III due to lack of predicate—but PMA isn’t appropriate
   
•  De Novo Submission Fees and Process
• A user fee applies for De Novo submissions. Refer to the current rates at MDUFA User Fees.
   
• Submissions must be formatted as an e-copy using eSTAR.
   
• Send the completed request through the CDRH Customer Collaboration Portal for official review.
   
•  How RAPS Can Help
• Our regulatory team supports every step of the De Novo process:
• Strategic pathway assessment
   
• eSTAR file preparation
   
• FDA portal submission
   
• Response to FDA feedback and follow-up queries
   
• Innovate with confidence.
  Let RAPS guide your De Novo classification journey with precision and experience.

• De Novo Submission Process & Timeline
• The De Novo submission process is designed to evaluate whether a novel medical device—without a legally marketed predicate—can be classified as Class I or II based on its risk profile. While similar in format to a 510(k) submission, the De Novo pathway follows its own structured review timeline.
•  Step-by-Step De Novo Review Process
•  Day 1 – Submission Receipt
• The FDA receives the submission, assigns a De Novo (DEN) tracking number, and issues an acknowledgement letter to the applicant.
   
•  Day 15 – Acceptance Review
• The FDA conducts an initial review to determine whether the file meets basic requirements.
   
• If incomplete, the submission is placed on RTA (Refuse to Accept) Hold until missing information is provided.
   
•  Day 60 – Substantive Review Begins
• The FDA evaluates whether any similar device has been legally marketed.
   
• If deficiencies are found, an Additional Information (AI) Request is issued, outlining what must be addressed.
   
•  Applicant Response – Within 180 Days
• The submitter must respond to any AI Request within 180 calendar days.
   
• Failure to respond within this window results in automatic withdrawal of the submission.
   
•  Final FDA Decision
• Grant: If the device is determined to be safe and effective under general and/or special controls, the FDA grants De Novo classification. The device may then be marketed and used as a predicate for future 510(k) submissions.
   
• Decline: If the FDA finds the evidence insufficient to support a lower-risk classification, the request is denied, and the device remains Class III, requiring PMA (Premarket Approval).
   
•  Withdrawal of De Novo Request
• The FDA may consider a De Novo request withdrawn if:
• The applicant voluntarily submits a written notice of withdrawal.
   
• The applicant fails to respond to an AI Request within 180 days.
   
•  How RAPS Can Help
• From eSTAR formatting to submission management and FDA communications, RAPS ensures your De Novo journey stays on track, reducing delays and improving approval confidence.