![FDA Revised Guidance on OTS Software: Description](https://www.regdesk.co/wp-content/uploads/2023/09/1-17.png)
Sep 21, 2023
United States
The new article highlights aspects related to the description of the software to be included in submissions associated with a medical device using it. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
Read More
![MHRA Guidance on IVD Regulations: Conformity Assessment Basics](https://www.regdesk.co/wp-content/uploads/2023/09/2-20.png)
Sep 20, 2023
MHRA
The new article addresses the aspects related to the conformity assessment procedures in vitro diagnostic medical devices should undergo in order to ensure their safety and proper performance. Table of Contents The Medicines and Healthcare Products Regulatory...
Read More
![FDA Guidance on Informed Consent: Language and Description](https://www.regdesk.co/wp-content/uploads/2023/09/2-19.png)
Sep 20, 2023
FDA
The new article highlights the aspects related to the language to be used for informed consent, and also to the description the authority expects the parties responsible for clinical investigations to provide to potential study participants. Table of Contents The Food...
Read More
![FDA Draft Guidance on Orthopedic Non-Spinal Bone Plates, Screws, and Washers: Non-Clinical Animal and Clinical Performance Testing](https://www.regdesk.co/wp-content/uploads/2023/09/1-12.png)
Sep 20, 2023
FDA
The new article covers regulatory matters related to non-clinical animal testing and alternatives thereto, as well as clinical performance testing and the approach to be applied when determining whether it is reasonably needed to collect additional data. Table of...
Read More
![MHRA Guidance on Registration Reliant on Expiring CE Certificates: Specific Scenarios](https://www.regdesk.co/wp-content/uploads/2023/09/2-3.png)
Sep 20, 2023
MHRA
The new article highlights the aspects related to placing certain medical devices on the market with the respective CE certificates expired or expiring soon. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA),the UK regulating...
Read More