FDA draft guidance offers clarity for mobile medical apps

ACT executive director Morgan Reed issued the following statement today in response to the FDA’s draft guidance that would exempt many low risk medical apps and devices from FDA review: Today's draft guidance continues the FDA's strong push towards innovation-friendly policies.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 [...]

By |2014-08-01T16:57:04-04:00August 1st, 2014|Uncategorized|

FDASIA: Federal Agencies Report on Medical App Regulation

  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. [...]

By |2016-12-21T00:14:28-05:00April 3rd, 2014|Blog|
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