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Non-Lab Diagnostics: FDA Regulatory Considerations | MoFo Life Sciences

The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As. ....

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U.S. Food and Drug Administration Kicks Off Fall with Several Impactful Medical Product Guidances | Wilson Sonsini Goodrich & Rosati

The U.S. Food and Drug Administration (FDA) is making efforts to modernize both the 510(k) approval process for medical devices and study designs for drugs and biologics. ....

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Modernizing the FDA's 510(k) Program for Medical Devices: Selection of Predicate Devices and Use of Clinical Data in 510(k) Submissions | Goodwin

On September 6, 2023, the US Food and Drug Administration (FDA) released a trio of draft guidances in its efforts to “strengthen and modernize” the 510(k) Program and provide for more. ....

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Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions

This guidance provides information for situations when clinical data may be necessary to demonstrate substantial equivalence in a 510(k) submission. ....

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Can What the Supreme Court Said About Device Clearance in Lohr, a "Derelict on the Waters of the Law," Finally Be Sunk?[1] | Butler Snow LLP

Even though they are still quoted, statements in Medtronic v. Lohr, which question whether FDA (Food & Drug Administration) medical device clearance is a judgment about a device’s. ....

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