The Digital Health Tsunami Is Here. How Is FDA Gearing Up?

Med Device Online –

In this “Insider’s View” column, Catalyst President Nancy Bradish Myers examines the coming wave of digital health, what FDA is signaling through its recent moves in the digital health space, and what companies might expect from a software precertification process. The column offers a close look into CDRH’s ongoing Software Precertification (Pre-Cert) Pilot Program, which will take a “firm-based” approach — rather than the traditional product-based approach — to regulate software. Ms. Myers considers pilot participants’ perspectives as well as the five FDA-generated excellence principles that CDRH’s Pre-Cert team is considering to evaluate digital health companies.