FDA draft guidance offers clarity for mobile medical apps

ACT executive director Morgan Reed issued the following statement today in response to the FDA’s draft guidance that would exempt many low risk medical apps and devices from FDA review:

Today’s draft guidance continues the FDA’s strong push towards innovation-friendly policies.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 new entrants to the field.

Health app makers continue to seek more clarity and simplification from the FDA and welcome today’s efforts to minimize the obstacles they face bringing new products to market.