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Quality System | FDA

Impact of FDA Adoption of ISO 13485

The FDA’s proposed rule to align its quality system regulation with ISO 13485 has the industry buzzing. What does it mean for medical device and IVD manufacturers? Let’s take a closer look at the proposed changes and what they might mean for manufacturers if they are adopted.
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FDA CDRH 2021: A Year in Review

By: Kevin Go, Project Engineer, RQM+ (former FDA CDRH Lead Reviewer) and Ryan Randall, Senior Engineer, RQM+ (former FDA CDRH Lead Reviewer). Looking back to 2020, as the COVID-19 pandemic gripped the world, much of the FDA’s focus turned to their response to the public health emergency. CDRH in particular reviewed thousands of emergency use authorization (EUA) applications and worked to facilitate the development and availability of COVID-19 tests and collection kits, personal protective equipment (PPE), ventilators, and other devices. Despite this shift in focus, CDRH also received an increase in “conventional” premarket submissions, such as 510(k)s, De Novos, Premarket Approvals (PMAs), Q-Submissions (Q-Subs), and surprisingly even IDEs. Overall, this amounted to a massive 38% increase to CDRH’s premarket submission workload).1
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New Guidance: FDA Safer Technologies Program (STeP) for Medical Devices

U.S. Food & Drug Administration (FDA) released the highly anticipated Safer Technologies Program (STeP) Guidance Document.
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