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Device-Related Guidelines - Worldwide Developments

This article was originally published in RAJ Devices

Executive Summary

Recently updated and newly issued documents.

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QUOTED. 13 July 2020. Fred Colen.

The US FDA’s Circulatory System Devices advisory panel will meet on 27 October to discuss the review of the premarket approval application of Neovasc’s Reducer device, which is intended to treat angina. See what Neovasc’s CEO Fred Colen said about it here.

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Expanding US FDA Mandatory Recall Authority To All Drugs Gets House Appropriators’ Approval

Appropriators’ FDA FY 2021 budget includes amendment to expand its mandatory recall authority introduced by chairman of subcommittee with oversight of agency’s budget, Rep. Sanford Bishop. He said the agency should be able to force drug product recalls as it already can for vaccines, medical devices and products containing ingredients also scheduled as controlled substances.

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