The FDA believes in digital health tools and is offering to help selected developers with the complex rules (that it created -Ed.) navigate the process if they are alleviating pain or reducing the use of opioids.
“Medical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in tackling the opioid crisis. We must advance new ways to find tools to help address the human and financial toll of opioid addiction,” said FDA Commissioner Scott Gottlieb, M.D.
For developers who are new to the FDA process this contest could provide substantial benefit in the form of a much smoother regulatory process not available to other applicants.
Meanwhile, the agency is also looking for public feedback on its restricted oversight of specific types of software (Mobile Medical Apps) as directed by the 21st Century Cures Act.