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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

There are two main aspects to FDA’s review policies and procedures:

  • Acceptance should not be based on a substantive review of the information provided in the De Novo request. The acceptance review is merely conducted to assess whether the De Novo request contains all necessary elements, not the adequacy of the information provided. Evaluation of quality only occurs after the request has been accepted.
  • FDA staff should determine whether the requester provided a justification for any alternative approach. The De Novo requester may provide rationale for why a certain criterion is not applicable to the device, and it is the FDA’s job to determine whether or not this is true.

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