The Digital Health Innovation Action Plan outlines the FDAs efforts to reimagine the FDA’s approach to ensuring all Americans have timely access to high-quality, safe and effective digital health products. As part of this plan, the FDA committed to several key goals, including increasing the number and expertise of digital health staff at the FDA, launching the digital health software precertification pilot program (“Pre-Cert”) and issuing guidance to modernize our policies.
FDA Commissioner’s Statement: Advancing new digital health policies to encourage innovation, bring efficiency and modernization to regulation
Federal Trade Commission (FTC) Mobile Health Apps Interactive Tool
If you are developing a mobile health app that collects, creates, or shares consumer information, click here to take you to the tool on Federal Trade Commission’s website to find out when FDA, Federal Trade Commission (FTC) or Office of Civil Rights (OCR) laws apply: