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![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.
This guidance serves as a primary resource to provide clarity regarding expectations for performance data for implanted medical devices.
Biosmiliars and Procedural
Classification Categories for Certain Supplements Under BsUFA III