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Tag: guidance RegDesk

FDA Guidance on Ethical Considerations for Clinical Investigations Involving Children: Study Procedures and Summary

The new article highlights the key points related to study procedures in pediatric clinical investigations, and also provides a summary of the key points...

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FDA Guidance on Distinguishing Medical Device Recalls from Enhancements: Key Concepts and Definitions

The new article describes in detail the main concepts used in the context of medical device recalls and enhancements in terms of determination of...

FDA Guidance on Abbreviated 510(k) Program: Overview

The article provides an overview of the regulatory policy related to the Abbreviated 510(k) Program and highlights the key points associated thereto.  ...

FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Overview

The article provides an overview of the regulatory policy for pivotal clinical investigations in terms of design considerations.  Table of Contents ...

HSA Guidance on Change Notification: Change Type Flowcharts

The new article provides an overview of flowcharts describing the change type assessment.  Table of Contents The Health Sciences Authority (HSA),...

FDA Guidance on Production Software Assurance: Record-Keeping

The new article describes in detail the aspects related to establishing the appropriate record for the assurance of the software used in the course...

FDA on Low-Risk Devices: Determining the Risk

The new article highlights the aspects related to the way the risk related to general wellness products should be determined.  Table...

Philippines Guidance on Abridged Processing of Applications: Overview

The article provides an overview of the existing regulatory requirements related to the abridged processing of applications for medical devices. Table...

FDA Guidance on Production Software Assurance: Appropriate Assurance Activities

The new article describes in detail the way the appropriate assurance activities should be determined.  Table of Contents The Food and...

FDA Guidance on Low-Risk Devices: Overview

The article provides an overview of the regulatory policy for low-risk medical devices.  Table of Contents The Food and Drug Administration...

HSA Guidance on Change Notification: FSCA-related Changes and Exemptions

The new article highlights the aspects related to the changes to registered medical devices implemented in response to adverse events, the context of field...

FDA Guidance on Production Software Assurance: Risk-Based Approach

The new article describes in detail the aspects related to a risk-based approach and the way it should be applied concerning computer software assurance...

FDA Guidance on the Least Burdensome Approach: Timing

The new article describes in detail the aspects related to timing for regulatory procedures in the context of the least burdensome approach.  ...

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