Food and Drug Administration

FDA: Digital Health Policy for Prescription Drug Pricing

New prescription drug-use related software proposed by FDA will help companies and develop an efficient pathway to help increase safety and effectiveness. Read on: www.natlawreview.com/article/significant-fda-digital-health-policy-development-prescription-drug-sponsors
Food and Drug Administration

Software as a Medical Device: FDA Update in May 2018

Until May 31, the U.S. Food and Drug Administration (FDA) has open for comment from the public a proposal for precertification of software as a medical device. Its 17-page proposal is located at https://www.fda.gov/downloads/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/ucm605685.pdf....