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Legal Minute: Decoding the FDA's prescription drug use related software guidance
Manage episode 398513309 series 3506216
محتوای ارائه شده توسط Darshan Kulkarni. تمام محتوای پادکست شامل قسمت‌ها، گرافیک‌ها و توضیحات پادکست مستقیماً توسط Darshan Kulkarni یا شریک پلتفرم پادکست آن‌ها آپلود و ارائه می‌شوند. اگر فکر می‌کنید شخصی بدون اجازه شما از اثر دارای حق نسخه‌برداری شما استفاده می‌کند، می‌توانید روندی که در اینجا شرح داده شده است را دنبال کنید.https://fa.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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