CDER Permits Some Combo Product Software To Be Submitted As DMFs
New draft guidance allows electronics or software that will be used across multiple combination products to be submitted as a Type V drug master file, potentially streamlining the assessment process.
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US FDA Hoping To Solve Drug-Software Issues With Digital Health Working Group
As more applications include software components, group wants assessors to apply best practices from CDRH to CDER whenever possible.
Combination Products: US FDA Aims For Limited Two-Application Solutions
In announcing guidance stating one application generally is sufficient for a combination product, FDA asks for comments on situations where two would be needed.
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.