June 1, 2017 Martin

Regulatory Plan

RHISE is a Class II medical device with no substantial equivalent. A Class II medical device has medium risk to the patient. We will be filing for commercial release through the U.S. Food and Drug Administration.

This will require a premarket approval (PMA) to show that the device satisfies these essential characteristics:

  • safe and effective
  • probable benefits outweigh probably risks
  • device will significantly help a large portion of the target population
  • pre-clinical studies will be used as sources of scientific evidence

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References

1. U. S. Food and Drug Administration. 2015 Nov 27 [accessed 2017 May 30].

https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm203018.htm