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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...
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.
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...
![Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions - Vimarsana News](https://www.fda.gov/themes/custom/preview/img/FDA-Social-Graphic.png)
This guidance provides information for situations when clinical data may be necessary to demonstrate substantial equivalence in a 510(k) submission.
![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 - Vimarsana News](https://jdsupra-static.s3.amazonaws.com/profile-images/hr.10610_1459.jpg)
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...