The Food and Drug Administration Safety and Innovation Act (FDASIA) Report

On April 3, HHS released the FDASIA report which presents a risk based framework for evaluating the safety of innovative devices and applications.

In issuing the report, the FDA took a very balanced view and did not expand its regulatory scope.    It defines the world of medical devices and applications as

1.  Administrative - i.e. something that reminds you about an appointment
2.  Wellness - i.e. something that reminds you to exercise, stay hydrated, and eat right
3.  Medical Device - i.e. something that measures a body signal and initiates a specific diagnosis or treatment.

#1 is not subject to regulation.   #2 will have oversight by ONC but no regulation.  #3 will be regulated by the FDA.

The FDA makes clear it will not focus on #2 and it will not regulate cell phones/smart phones because a mobile medical application can be operated on one.   Devices that perform wellness management will not require registration or product listing.

Given the responsibilities assigned to ONC, it�s likely ONC will have to add staff with device and mHealth expertise.   The language in the report suggests that ONC�s standards and best practices for wellness applications will be voluntary.

It�s always a challenge to balance innovation and government regulation.  The idea of harm reduction through a risk-based framework makes great sense.