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FDA Roundup: March 31, 2023

FDA Roundup: March 31, 2023
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FDA will refuse new medical devices for cybersecurity reasons on Oct. 1

The FDA intends to start rejecting medical devices for cybersecurity reasons in October, but new submissions must include plans beginning March 29.
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Be Prepared: FDA Signals Transition Countdown for Medical Devices Marketed Under COVID-Era Enforcement Policies, EUAs | Wiley Rein LLP

On October 17, 2022, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released the list of guidance documents proposed for publication in. ....

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Are you Submission Ready? FDA Medical Device Submission Tips & Tricks | Gardner Law

Companies often come to us when they feel that they are ready to submit their medical device to the FDA for clearance or approval, but Medical Technology newcomers may not realize the. ....

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Not Just a Rubber Stamp: FDA Revises Its 510(k) Refuse to Accept Policy | Faegre Drinker Biddle & Reath LLP

Is the decision to submit a 510(k) application versus a Premarket Application (PMA) at the sole discretion of a medical device manufacturer? The answer is not always clear to product. ....

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