“…Advancing digital health is one of several priorities for FDA in the coming year, according to a 2018 Strategic Policy Roadmap released (PDF) by the agency on Thursday that identified four priority areas “that will be the focus of additional policy activity in 2018.”
“In particular, the FDA plans to publish finalized guidance clarifying when digital health technology falls under the FDA’s regulatory purview and when the agency plans to exercise enforcement discretion. Unsurprisingly, the agency also plans to advance its software precriticization program after launching a pilot program in September involving nine companies including Apple and Fitbit….”
Source: FDA maintains its focus on digital health in 2018 – January 12, 2018, By Evan Sweeney, FierceHealthcare. Read the full article here.