regulatory guidance Archives

Feb 19, 2024

FDA Draft Guidance on Remote Regulatory Assessments: Overview

The article highlights the critical points associated with the existing regulatory framework for remote regulatory assessments.

FDA Draft Guidance on Evidentiary Expectations for 510(k) Implant Devices: Overview

Feb 19, 2024

FDA

FDA Draft Guidance on Evidentiary Expectations for 510(k) Implant Devices: Overview

The article highlights the key points associated with the concept of evidentiary expectations in the context of marketing submissions.

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Credibility Evidence Part 1

Dec 28, 2023

FDA

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Credibility Evidence Part 1

A comprehensive overview of three essential aspects of computational modeling: code verification results, model calibration evidence, and bench test validation results.
Each of these plays a vital role in ensuring the accuracy and reliability of computational models in various scientific and engineering domains.

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Credibility Evidence Overview

Dec 28, 2023

FDA

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Credibility Evidence Overview

The article describes in detail the approach to be applied when assessing the credibility evidence responsible parties are expected to submit.

Dec 20, 2023

FDA

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Credibility Evidence Overview

The article describes in detail the approach to be applied when assessing the credibility evidence responsible parties are expected to submit.

RegDesk Regulatory Roundup

FDA Draft Guidance on Remote Regulatory Assessments: Overview

FDA Draft Guidance on Evidentiary Expectations for 510(k) Implant Devices: Overview

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Credibility Evidence Part 1

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Credibility Evidence Overview

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Credibility Evidence Overview

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