Tips & Tricks: Regulatory Path

  • Create an outline of the regulatory plan that will enable marketing approval of your technology/product.
  • Determine which FDA division is likely to have oversight for development and approval by visiting as direct consultation with the appropriate FDA Division is an essential step to ensure the smoothest possible design and conduct of a development plan that will lead to approval.
  • To determine the class of your device you need its regulation number.  The regulation number can be found through the FDA classification database or through the FDA device panel to which your device belongs.