FDA De Novo Classification | Evaluation of Automatic Class III Designation

Section 513(f)(2) of the Act, also referred to as de novo classification or Evaluation of Automatic Class III Designation, was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012. This new law provides two options for de novo classification.

  • First, any person who receives a “not substantially equivalent” (NSE) determination in response to a 510(k) for a device that has not been previously classified under the Act may, within 30 days of receiving notice of the NSE determination, request FDA to make a risk-based classification of the device under section 513(a)(1) of the Act.
  • Alternatively, any person who determines that there is no legally marketed device upon which to base a determination of substantial equivalence may request FDA to make a risk-based classification of the device under section 513(a)(1) of the Act without first submitting a 510(k). For further information, please refer to our current guidance on the de novo process.

Medical Device Amigo

Remote Catheter System

  • De Novo Number: DEN140009
  • Regulation Number: 870.5700
  • Classification Product Code: PJB
  • Date Received: 02/18/2014
  • Decision Date: 12/18/2014
  • Classification Advisory Committee: Cardiovascular
  • Review Advisory Committee: Cardiovascular

FDA Guidance: New Section 513(f)(2) – Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff

Download “New Section 513(f)(2) - Evaluation of Automatic Class III Designation” ucm080197.pdf – Downloaded 215 times – 46 KB

 
 
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