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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- Commission publishes guidelines on transparency obligations for providers and deployers of certain AI systems
- MDCG Position Paper: UDI assignment between manufacturers and distributors
- EMA Questions & answers on Article 31 non-pharmacovigilance referral procedures
- EXTENSION OF THE MDR TRANSITIONAL PERIOD AND REMOVAL OF THE ‘SELL OFF’ PERIODS
- MHRA Updated guidance for the International Recognition Procedure (IRP)
- MDCG 2021-5 Rev. 1 .Guidance on standardisation for medical devices
- Qualification of novel methodologies (QoNM) for medicinal product development . Procedural Guidance to applicants
- FDA Guidance for Drug Development