Victoria Calhoon

Victoria Calhoon

Faegre Drinker Biddle & Reath LLP

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Not Just a Rubber Stamp: FDA Revises Its 510(k) Refuse to Accept Policy

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 liability lawyers, judges, and juries. FDA...more

5/9/2022  /  510(k) RTA , Federal Industry Standards , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Premarket Approval Applications , Regulatory Standards
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