FDA Archives

Nov 29, 2023

FDA Guidance on CFG Requests: Specific Aspects

The new article highlights the key points related to the requests, the way they should be submitted, as well as the relevant processes and procedures associated thereto.

FDA Guidance on Electronic Thermometers: Overview

Nov 22, 2023

FDA

FDA Guidance on Electronic Thermometers: Overview

The article provides an overview of the existing framework for electronic thermometers.

FDA Guidance on Electronic Submissions for 510(k): Current Template

Nov 16, 2023

FDA

FDA Guidance on Electronic Submissions for 510(k): Current Template

The new article highlights the aspects related to the current version of the electronic submission template and outlines the key points to be considered by submitters (applicants).

FDA Revised Guidance on MR Safety: MRI Safety Labeling

Nov 9, 2023

FDA

FDA Revised Guidance on MR Safety: MRI Safety Labeling

The new article describes in detail the aspects related to different types of MRI safety labelling to be used to indicate the safety status of the device intended to be marketed and used in the US.

FDA Guidance on Non-Invasive Remote Monitoring Devices: Overview

Nov 1, 2023

FDA

FDA Guidance on Non-Invasive Remote Monitoring Devices: Overview

The article provides an overview of the revised guidance document issued by the US authority to address certain regulatory matters and ensure legal clarity.

RegDesk Regulatory Roundup

FDA Guidance on CFG Requests: Specific Aspects

FDA Guidance on Electronic Thermometers: Overview

FDA Guidance on Electronic Submissions for 510(k): Current Template

FDA Revised Guidance on MR Safety: MRI Safety Labeling

FDA Guidance on Non-Invasive Remote Monitoring Devices: Overview

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