FDA Pre-Cert

The HIMSS Media team gives a recap of recent headlines surrounding the FDA, COVID-19 and new digital health software products.

Somryst, a prescription digital therapeutic combining cognitive behavioral therapy and personalized sleep restriction, is the first software product to put the FDA's early Precertification Program framework through its paces. 

This half of the year the FDA has named a new comissioner, continued working on the much anticipated Pre-Cert program and collaborated with the NIH on a new app. 

Epstein Becker & Green's Bradley Merrill Thompson explains why the FDA PreCert Program's built-in subjectivity and bias toward established entities should worry the healthcare and medical technology industry.

Digital therapeutic stakeholders came together at this week's DTx East conference to discuss the state of digital health investment, developing successful business models, the need for robust data and more.

CEO and President Dr. Corey McCann said that Somryst, a digital treatment for chronic insomnia and depression, is the first software as a medical device product to be submitted through the regulator's pilot pathway. 

At BIO 2019 in Philadelphia, a panel of industry experts discussed their experiences with the FDA's pilot program; ambiguities in drug, device and software pathways; and the hurdles digital health regulation has yet to properly address.

Companies planning an upcoming De Novo or 510(k) submission for their software medical device are eligible, but participation will not yield precertification.

A collaborative attitude and a commitment to strenuous review have characterized the process so far.

The FDA’s Pre-Cert program has fallen under new scrutiny as the agency received an open letter today from three senators: Elizabeth Warren (D-Mass.