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Why the FDA Withdrew Dozens of Proposed 510(k) Exemptions June 15, 2021 - In March and April 2020, the Food and Drug Administration (FDA) issued guidance aimed at expanding the availability of certain medical devices that were critical in fighting COVID-19, such as ventilators, respiratory devices, sterilizers,… Read More
FDA Remote Interactive Evaluations Part 2: What to Expect June 10, 2021 - Due to the limitations inflicted by the pandemic, Remote Interactive Evaluations (RIEs) are becoming an important part of regulatory decision-making. Specifically, the FDA is using RIEs to limit unnecessary contact. Read More
5 Ways to Measure the Cost of Nonconformances May 27, 2021 - How much does quality cost your company? Read More
