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October 03, 2019

FDA Provides Clarity on Digital Health Policies

On September 26, the FDA issued guidance related to its plans to regulate software designed to aid clinical decision-making. The FDA issued draft guidance on clinical decision support software (CDS) that sets forth the FDA’s proposed approach to regulating CDS, including software that incorporates machine learning technology. Second, the FDA issued final guidance on what software may fall outside the FDA’s interpretation of what constitutes a medical device pursuant to the 21st Century Cures Act, indicating that certain mobile apps designed to help encourage or maintain a healthy lifestyle may pose a low risk to patients, but provide great value. Finally, the FDA also updated four previous final guidances for tech-enabled products to align with the 21st Century Cures Act: mobile medical apps; general wellness and low-risk devices; off-the-shelf software use; and data systems, medical image storage, and communication devices.