RegDesk Regulatory Roundup

Oct 27, 2023

FDA Guidance on Considerations for Weight Loss Devices: Treatment Protocols, Endpoints and Adverse Events

The article describes in detail the approach to be applied with respect to clinical performance testing considerations including, inter alia, the ones associated with treatment parameters and protocols, safety and effectiveness endpoints and data, as well as adverse events

FDA Guidance on Physiologic Closed-Loop Control Technology: Non-Clinical Testing

Oct 25, 2023

FDA

FDA Guidance on Physiologic Closed-Loop Control Technology: Non-Clinical Testing

The new article highlights the aspects related to non-clinical testing considerations related to the devices covered by the scope of the guidance.

FDA Guidance on Considerations for Weight Loss Devices: Study Design, Duration, and Follow-Up

Oct 20, 2023

FDA

FDA Guidance on Considerations for Weight Loss Devices: Study Design, Duration, and Follow-Up

The article provides an overview of the new regulation and highlights the key points associated thereto.

Oct 12, 2023

Canada

Health Canada Guidance on Medical Device Application Types: IVDDs

The article highlights the key points related to the regulatory status of in vitro diagnostic medical devices. Table of Contents Health Canada, the Canadian healthcare product regulatory authority, has released a draft guidance on determining medical device...

CE Marking Guide for Medical Devices in the European Union

Oct 12, 2023

Africa

CE Marking Guide for Medical Devices in the European Union

This article highlights what CE marking is, how to obtain it, and the steps to follow to comply with EU regulations. Table of Contents Medical devices manufacturers willing to market products in the European Union (EU), must comply with the regulations established...

RegDesk is recognized as a Regulatory Intelligence Representative Vendor! Learn more by reading the 2024 Gartner® Market Guide for Regulatory Intelligence Solutions.

Get the report