March 17, 2021

Refuse to Accept Policy


Refuse To Accept outlines the basis on which the FDA decides whether a 510(k) submission meets required acceptability standards and if it should be further considered for a substantive review. In order to do this, the RTA has in place a checklist consisting of 39 questions, for Traditional application. The applicant is required to answer in yes, no and not applicable.

The domains under which the questions are classified are as follows:

  1. Administrative
  2. Device Description
  3. Substantial Equivalence Discussion
  4. Proposed Labeling
  5. Sterilization
  6. Shelf Life
  7. Biocompatibility
  8. Software
  9. Electrical Safety and EMC
  10. Performance Data – General
  11. Performance Characteristics – In Vitro Diagnostic Devices Only

The RTA was revised by FDA on the 4th of August 2015, and will go into effect on October, 1, 2015. There are few major changes incorporated in the revised RTA checklist,

  1. Separate checklists for each of the 510(k) submissions, namely Traditional, Abbreviated, Special. Though the overview is the same, the specifications are different
  2. The total number of questions in the checklist was diminished to 39

For more information on the RTA questions, checklists and for assistance on filling them up faultlessly, get in touch with us at

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