Baxter, digital health startups lead pushback against 510(k) exemptions

In making the case for change, HHS quoted survey data on the cost and timelines of the 510(k) pathway. Respondents said bringing low-to-moderate risk 510(k) devices to market costs around $31 million, $24 million of which is spent on activities related to FDA. The average wait from first filing to clearance at the time of …

Baxter, digital health startups lead pushback against 510(k) exemptions Read More »