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Legal Minute: Decoding the FDA's prescription drug use related software guidance
Manage episode 398513309 series 3506216
Contenu fourni par Darshan Kulkarni. Tout le contenu du podcast, y compris les épisodes, les graphiques et les descriptions de podcast, est téléchargé et fourni directement par Darshan Kulkarni ou son partenaire de plateforme de podcast. Si vous pensez que quelqu'un utilise votre œuvre protégée sans votre autorisation, vous pouvez suivre le processus décrit ici https://fr.player.fm/legal.
FDA Issues Crucial Guidance on Prescription Drug Software!
Darshan Kulkarni delves into the FDA's recent guidance on prescription drug-related software. The discussion revolves around three key considerations:
1. software functions,
2. end-user output, and
3. regulatory guidelines.
Notably, the FDA emphasizes distinguishing between functions relying on direct device data transfer and those that don't. The document also outlines the significance of characterizing software output, such as symptom data and alerts. Lastly, regulatory guidelines stress that functions not directly transferring device information should be omitted from product information unless essential for safe use, with details to be determined on a case-by-case basis. Tune in for expert insights into this pivotal FDA update!
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