digital health regulation
A new report from PwC predicts that new and proposed FDA regulations could open up doors for pharmaceutical companies looking to develop digital tools.
Released yesterday, the document outlines FDA's preference toward single applications for combination products.
To encourage healthcare technology innovation and update the 510(k) pathway, the regulatory agency said that it will soon release measures aimed to sunset predicate devices that are over a decade old.
The agency's proposal would classify the majority of software released by pharmas as "promotional labeling" that would not require premarket review.
The results to our poll about the FDA program prompt questions about the program's fairness to companies big and small.
The agency has reinvented the process for clearing digital health products but reviews are mixed.
A brain training game fined by the FTC earlier this year.
By Bradley Merrill Thompson
With the growth of health apps, entrepreneurs often need to determine if FDA regulates their particular mobile app.
Bradley Merrill Thompson
At the end of last week the FDA posted two draft guidance documents related to digital health.
Last month iMedicalApps' Dr.