FDA and digital health, a marriage…

… “in the making” might be the best way to describe the relationship. On one side, the FDA has recently approved 14 new digital health products. On the other side, recent FDA guidance leads Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in FDA law to say, “Industry wants faster approvals. FDA wants more control over industry. So, FDA’s proposing an exchange: faster approvals for more FDA authority.” All this hullabaloo centers on whether FDA should certify every digital health product or can they certify digital health at the company level. We don’t know. What we do know is that digital health is hot, really hot, like there’s been $1.62B invested in digital health companies in Q1 2018. That’s $18M per day. Per day! Prefer smaller numbers? It’s $12,500 per minute. Muy caliente.