Drawing the Device Line: FDA Seeks Public Input on Patient Safety and Non-Device Health Software

Key Takeaways The FDA is requesting public comments by August 13, 2026, on the patient safety impacts of software functions excluded from the medical device definition under the 21st Century Cures Act, including clinical decision support and data transfer and display software. Companies developing remote patient monitoring, CDS and other health software should evaluate whether their products qualify for statutory exclusions under FD&C Act Section 520(o)(1), as small functionality differences can determine … Continued