In our last post, we took a brief look back through history at FDA’s approach to regulating medical device software and found that there is little distinction from the agency’s approach to hardware devices. Recently,...more
You’d be forgiven in the current climate of coronavirus and election season, to name just a couple hot issues of the day, for missing two recent announcements from the FDA about its digital health program. On September 14,...more
On September 14, 2020, the U.S. Food and Drug Administration (FDA) released an update on the status of its Software Precertification (Pre-Cert) Program. It is the only public update on the program in 2020. According to the...more
In light of the 2019 novel coronavirus (COVID-19) outbreak, the Centers for Medicare & Medicaid Services (CMS) has suspended survey activity for all nonemergency state survey inspections except for initial certification and...more
In response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive, risk-based approach to regulating digital health products. Software...more
Regular readers of this blog know that we’re closely following the FDA’s proposed regulatory framework for software as a medical device (SaMD), known as precertification—Pre-Cert for short. Generally, Pre-Cert involves a...more
On January 7, 2019 the U.S. Food and Drug Administration (“FDA”) issued three new documents related to the Agency’s Software Precertification (“Pre-Cert”) Pilot Program. These documents include (1) the Developing a Software...more
The federal government shutdown that began at midnight December 29, 2018 shows no sign of ending soon. The Federal Communications Commission tapped on-hand funds to continue operations uninterrupted but ran out of time – and...more
The U.S. Food and Drug Administration (FDA) recently updated its software Precertification Program. A working program was originally rolled out in April 2018, but the program was updated in response to requested public input....more
On April 26, 2018, the U.S. Food and Drug Administration ("FDA") released an initial working model for its Software Precertification ("Pre-Cert") Pilot Program. The Pre-Cert Program is an effort by FDA to develop a new, more...more
The FDA may begin certifying the laboratories that produce lab-developed tests (“LDTs”) instead of drafting regulatory rules to cover the tests themselves....more
In another example of the FDA's revision of regulatory policies for digital health products, Commissioner Scott Gottlieb announced on Nov. 6, 2017, that the agency is extending its precertification model to low-risk...more
The Food and Drug Administration (FDA) continues to flesh out its ideas for regulation of digital health. Last week, the agency published a notice in the Federal Register, announcing a pilot program to evaluate a “new...more
In recognition that the traditional regulatory approach toward moderate to high risk medical devices is not well-suited for current digital health software products, the US Food and Drug Administration published a Digital...more