ACT executive director Morgan Reed issued the following statement today in response to the FDA’s draft guidance that would exempt many low risk medical apps and devices from FDA review: Today's draft guidance continues the FDA's strong push towards innovation-friendly policies. This clarification will help provide a clearer path for [...]
The FDASIA report on Health IT and its impact on mobile medical apps was released today. FDASIA is a combined effort from federal agencies including the FDA, FCC, and HHS. ACT is pleased that the FDASIA recommendations promote medical app innovation within a risk-based framework that protects patient safety. [...]
Today six Senators issued a public request for clarity on FDA regulation of mobile medical apps. Earlier this year, ACT toured the country speaking to app makers and venture capitalists about opportunities in the mHealth field. I am pleased to see the Senate is seeking further clarity on the regulation [...]
Association for Competitive Technology executive director Morgan Reed issued the following statement in response to today’s request by six Senators for more clarity on FDA’s regulation of mobile medical apps. Earlier this year, Mr. Reed toured the country speaking to app makers and venture capitalists about opportunities in the [...]