Category: FDA Updates

FDA Updates

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FDA Updates

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Monitoring Coronavirus-Related Supply Chain Shortages

The FDA has been closely monitoring the supply chain with the expectation that the COVID-19 outbreak would likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S

FDA Updates

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Draft Guidances

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FDA Takes Steps to Modernize 510(k) Medical Device Program

The U.S. FDA has announced that, as a first step toward implementation of the recently established Safety and Performance Based Pathway for medical devices, the agency is issuing draft guidances outlining the recommended premarket performance criteria and testing methodologies for four specific types of devices.