Drug/Software Combos Likely Won't Require Pre-Market Review By US FDA
But sponsors should sometimes seek advisory comment. Agency explains that most drug-use-related apps will be considered promotional labeling. FDA seeking feedback from a variety of stakeholders on its discussion proposal for regulating prescription-focused software.
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All three areas need work following enactment of the original 21st Century Cures Act, authors Fred Upton and Diana DeGette write in vision statement.
As more applications include software components, group wants assessors to apply best practices from CDRH to CDER whenever possible.
New draft guidance from the US agency allows electronics or software that will be used across multiple combination products to be submitted as a Type V drug master file (DMF), potentially streamlining the assessment process.