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Feb 2, 2023

FDA Revised Guidance on COVID-19 Tests: Laboratory-Developed Tests and Tests Under Review

The new article highlights the aspects related to the use of tests developed by certified laboratories, as well as the ones being reviewed by the authority. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...

MDA Draft Guidance on Medical Device Certificates: Information and Documentation

Feb 2, 2023

Malaysia

MDA Draft Guidance on Medical Device Certificates: Information and Documentation

The new article highlights the aspects related to the scope of information and documentation the authority expects to be included in requests from interested parties. Table Of Contents: The Medical Device Authority (MDA), a Malaysian regulating authority, has...

FDA Revised Policy for COVID Tests: Key Points

Feb 2, 2023

FDA

FDA Revised Policy for COVID Tests: Key Points

The new article provides an overview of the revised guidance document and outlines the key points associated thereto. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...

TGA Guidance on Reclassification of Medical Devices in Direct Contact with the Heart, CCS, and CNS

Feb 2, 2023

Australia and Oceania

TGA Guidance on Reclassification of Medical Devices in Direct Contact with the Heart, CCS, and CNS

The article provides an overview of the new classification rules for certain medical devices recently introduced in Australia. Table Of Contents: The guidance is intended to provide medical device manufacturers and other parties involved in manufacturing medical...

FDA Guidance on Content of Human Factors Information: Overview

Feb 2, 2023

FDA

FDA Guidance on Content of Human Factors Information: Overview

The new article provides an overview of the regulatory requirements related to the information on human factors to be submitted when applying for marketing approval. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...

RegDesk Regulatory Roundup

FDA Revised Guidance on COVID-19 Tests: Laboratory-Developed Tests and Tests Under Review

MDA Draft Guidance on Medical Device Certificates: Information and Documentation

FDA Revised Policy for COVID Tests: Key Points

TGA Guidance on Reclassification of Medical Devices in Direct Contact with the Heart, CCS, and CNS

FDA Guidance on Content of Human Factors Information: Overview

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