• The FDA’s Race To Catch Up With Digital Medicine

    The FDA’s Race To Catch Up With Digital Medicine

    The Food and Drug Administration announced an initiative in June, which would ramp up regulations in the digital health space. The announcement comes close after the 21st Century Cures Act which, among several proposals, starts to outline the role of FDA in overseeing digital health.It further clarified its plans with regard to regulation of digital health technologies in a new blog post last July. The most notable announcement was the new Pre-Cert for Software Pilot Program.The pre-cert program has important inclusion criteria that limit participants to those developing a “software product that meets the definition of a medical... Read More