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Planning for the End: FDA Issues Draft Guidance for Transitioning EUA and Enforcement Policy Medical Devices Marketed During the Pandemic | Goodwin

During the COVID-19 public health emergency, the United States Food and Drug Administration (FDA) has issued hundreds of Emergency Use Authorizations (EUAs) and numerous enforcement. ....

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FDA Outlines Post-Pandemic Plan For Medical Devices Now Marketed Under Special COVID Rules - Food, Drugs, Healthcare, Life Sciences

The U.S. Food and Drug Administration (FDA) recently announced its plan to provide medical device manufacturers 180 days to secure marketing authorization or clearance for medical devices. ....

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FDA Outlines Post-Pandemic Plan for Medical Devices Now Marketed Under Special COVID Rules | Holland & Knight LLP

The U.S. Food and Drug Administration (FDA) recently announced its plan to provide medical device manufacturers 180 days to secure marketing authorization or clearance for medical. ....

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FDA Opens the Pre-Sub Program to Compliance Actions, Including Form 483s and Warning Letters | Morgan Lewis

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Considering the tight timeline for preparing responses to FDA compliance actions coupled with the agency’s expectation for timely implementation of corrective and preventive actions, the benefit of obtaining feedback through the Q-submission program (also referred to as a “pre-submission”) may be limited.
To start off the new calendar year, FDA issued a revised version of its guidance document on the Q-submission program on January 6, 2021, “
Obtaining feedback on submissions that may qualify for FDA’s recently announced Safer Technologies Program (STeP), also launched on January 6, 2021 (see
Guidance Document). The STeP Program provides an expedited review and authorization process for certain device and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition ....

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