New class of therapeutics calls for new regulations: thoughts on the FDA’s new process for regulating digiceuticals
Tess Niewood
November 15, 2018
Interest and investment in digital health has increased rapidly in recent years. Some digital health software is impactful enough that it requires FDA approval, but current regulatory pathways are slow and cumbersome for tech companies. In July 2017 the FDA announced a beta-test of a new pathway, the pre-certification program, which is intended to increase innovation and minimize barriers to market entry for digital health software. While early signs show the program will have these intended consequences, it also may create an uneven playing field for incumbent players relative to