RegDesk Regulatory Roundup -- Medical Device and Pharma

Oct 13, 2023

BfArM Guidance on Fast-Track Process for Digital Health Applications: Temporary and Permanent Admission

The new article highlights the aspects related to the temporary and permanent admission of digital health applications. Table of Contents The German regulating authority in the sphere of healthcare products, the Federal Institute for Drugs and Medical Devices...

FDA Guidance on Considerations for Weight Loss Devices: Overview

Oct 13, 2023

FDA

FDA Guidance on Considerations for Weight Loss Devices: Overview

The article highlights the key points related to the regulatory status of the products based on the existing legal framework. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...

FDA Guidance on Physiologic Closed-Loop Control Technology: Definitions and Risk Management

Oct 13, 2023

FDA

FDA Guidance on Physiologic Closed-Loop Control Technology: Definitions and Risk Management

The new article highlights the aspects related to design considerations in the part of risk management. The document also provides an overview of the most important terms and concepts used. Table of Contents The Food and Drug Administration (FDA or the Agency), the...

HSA Guidance on IVD Registration Submissions: Manufacturing Information

Oct 13, 2023

HSA

HSA Guidance on IVD Registration Submissions: Manufacturing Information

The new article highlights the aspects related to the information to be included in the submissions with respect to manufacturing processes and sites involved. Table of Contents The Health Sciences Authority (HSA), a Singapore’s regulatory agency in the sphere of...

FDA Guidance on Physiologic Closed-Loop Control Technology: Overview

Oct 13, 2023

FDA

FDA Guidance on Physiologic Closed-Loop Control Technology: Overview

The article highlights the key points related to the regulatory status of the products in question and describes the approach to be followed. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...

FDA Guidance on Antimicrobial Susceptibility Test System Devices: Specific Aspects

Oct 12, 2023

FDA

FDA Guidance on Antimicrobial Susceptibility Test System Devices: Specific Aspects

The article addresses the aspects related to the existing legal framework associated with AST system devices and highlights the key points to be considered. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...

RegDesk Regulatory Roundup

BfArM Guidance on Fast-Track Process for Digital Health Applications: Temporary and Permanent Admission

FDA Guidance on Considerations for Weight Loss Devices: Overview

FDA Guidance on Physiologic Closed-Loop Control Technology: Definitions and Risk Management

HSA Guidance on IVD Registration Submissions: Manufacturing Information

FDA Guidance on Physiologic Closed-Loop Control Technology: Overview

FDA Guidance on Antimicrobial Susceptibility Test System Devices: Specific Aspects

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