North America Archives

Dec 14, 2021

FDA Guidance on the Content of Premarket Submission for Device Software Functions: Documents in Detail

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to the content of premarket submission for device software functions. The document is intended to provide...

FDA Guidance on Safety and Performance Based Pathway

Dec 13, 2021

FDA

FDA Guidance on Safety and Performance Based Pathway

The first article of the cycle provides a brief overview of the Safety and Performance Based Pathway, the ideas behind it, and key underlying concepts. The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices,...

FDA Draft Guidance on Content of Premarket Submissions for Device Software Functions: Introduction

Dec 10, 2021

FDA

FDA Draft Guidance on Content of Premarket Submissions for Device Software Functions: Introduction

The first article of the cycle provides an overview of the regulatory background for device software functions and describes the applicability of the respective draft guidance document issued by the FDA. The Food and Drug Administration (FDA or the Agency), the US...

FDA Guidance on Premarket Submissions for Device Software Functions: Definitions and Documentation

Dec 8, 2021

FDA

FDA Guidance on Premarket Submissions for Device Software Functions: Definitions and Documentation

The second entry in our cycle covering FDA Guidance on premarket submissions for medical device software, this article describes the way the manufacturers shall determine the scope of information to be submitted to substantiate their applications and also provides...

Dec 3, 2021

FDA

FDA Guidance on GUDID: Modules

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to the Global Unique Device Identification Database (GUDID). The document is intended to provide medical...

FDA Guidance on Software Validation Activities: Testing by the Developer

Dec 2, 2021

FDA

FDA Guidance on Software Validation Activities: Testing by the Developer

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to software validation. The document provides an overview of the main...

RegDesk Regulatory Roundup

FDA Guidance on the Content of Premarket Submission for Device Software Functions: Documents in Detail

FDA Guidance on Safety and Performance Based Pathway

FDA Draft Guidance on Content of Premarket Submissions for Device Software Functions: Introduction

FDA Guidance on Premarket Submissions for Device Software Functions: Definitions and Documentation

FDA Guidance on GUDID: Modules

FDA Guidance on Software Validation Activities: Testing by the Developer

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