Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will ...

The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and ...

On January 6, 2026, the US Food and Drug Administration (FDA) issued two revised guidance documents relating to general ...

The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD). The guidance is presented as representing the FDA's current thinking on ...

InstantGMP categorizes software functions into low, moderate, and high process-risk groups. Low-risk features, such as equipment, room, deviation, and CAPA logs, primarily collect or tabulate data.

The draft is a near total overhaul of the document finalized by FDA in 2005, with only short sections on topics such as software verification and the history of software revisions surviving unchanged.

The FDA's planned rollback of oversight shifts risk onto patients and clinicians ...

Dublin, Jan. 07, 2026 (GLOBE NEWSWIRE) -- The "FDA's 21 CFR Part 11 Add-on Inspections (Jan 12, 2026)" training has been added to ResearchAndMarkets.com's offering. The verification and validation of ...

Korrapati's implementation work is complemented by industry engagement, including presenting on CSA implementation and roadblocks at professional venues ...