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FDA Guidance on Considerations for Weight Loss Devices: Benefit-Risk Assessment

Oct 31, 2023

FDA

FDA Guidance on Considerations for Weight Loss Devices: Benefit-Risk Assessment

The article provides a general overview of the existing regulatory framework associated with adverse events.

FDA Guidance on Physiologic Closed-Loop Control Technology: Human Factors Testing and Labeling

Oct 27, 2023

FDA

FDA Guidance on Physiologic Closed-Loop Control Technology: Human Factors Testing and Labeling

The article provides a general overview of the existing regulatory framework associated with adverse events.

Oct 27, 2023

EDA

EDA Guidance on Reporting Adverse Reactions: Overview

The article provides a general overview of the existing regulatory framework associated with adverse events.

FDA Guidance on Considerations for Weight Loss Devices: Statistical Analysis and Pediatric Studies

Oct 27, 2023

FDA

FDA Guidance on Considerations for Weight Loss Devices: Statistical Analysis and Pediatric Studies

The article provides a general overview of the existing regulatory framework associated with adverse events.

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

Oct 27, 2023

FDA

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

RegDesk Regulatory Roundup

FDA Guidance on Considerations for Weight Loss Devices: Benefit-Risk Assessment

FDA Guidance on Physiologic Closed-Loop Control Technology: Human Factors Testing and Labeling

EDA Guidance on Reporting Adverse Reactions: Overview

FDA Guidance on Considerations for Weight Loss Devices: Statistical Analysis and Pediatric Studies

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

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