'Cures' Bill Circumvents FDA On Medical Software Regs
Lobbyists for the medical software industry, and particularly clinical decision support tools are "delighted" that lawmakers are getting around the agency by explicitly stating the types of software it is not allowed to regulate in the 21st Century Cures Act, set to pass Congress by the end of the year.
You may also be interested in...
FDA Publishes Final Guidance On Clinical Decision Support Software, Clarifies What Software Should Be Regulated As Medical Devices
In its final document, the US FDA outlines its interpretations of the four criteria for excluding clinical decision support software from being regulated as medical devices under federal law. Software must meet all four criteria to be excluded.
The US Congress and FDA have established that the agency will only oversee high-risk clinical decision-support (CDS) software, but a key CDS industry groups says too much ambiguity remains. The Clinical Decision Support Coalition has published guidelines in a bid to allow industry to self-regulate as much as possible.
Hiring experts in artificial intelligence, cloud computing, cybersecurity and related fields is a central part of US FDA's recently announced "Digital Health Innovation Action Plan." The goal of the expanded team will be to make better regulatory decisions, issue new guidances and initiate a "pre-certification" pilot program for software.