FDA is issuing this guidance to allow manufacturers to provide user manuals accompanying electronic products in either paper or electronic form. This is done to recognize that electronic media are now being widely used to provide instruction, while at the same time reducing paper consumption, increasing accessibility and providing rapid means for editing and updating content.
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- Product Management Services (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
- AI Omnibus enters into force
- EU CTR Q&A Version 7.3 is Out
- New WHO guide on Artificial intelligence-related health research
- GDP for APIs: APIC Publishes Updated “How to Do” Document
- Team-NB Position Paper :TRANSFER AGREEMENT FOR SURVEILLANCE OF LEGACY DEVICES
- MDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus document
- New ISO Guidance for AI-Powered Medical Devices: ISO/TS 24971-2:2026 Published!

