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Is it possible to identify all 510k records of medical devices were a FDA review or clinical trials is available (e.g. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K151502) using either the API, the dataset (https://open.fda.gov/apis/device/510k/download/) or any other database?

Records with a summary/statement can easily be identified by statement_or_summary in the provided dataset.

Update:

Just saw that the online search mask (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm) offers a box to filter results with clinical trials. Is this information also available with the api or the /device/510k data file?

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I'm Jack with the openFDA team. To my knowledge none of the fields in the openFDA 510k API flag the record as a clinical trial. There are no plans to add this at present.

Thank you, Jack Finch

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  • Thank you for your help. I assume the same applies to FDA reviews? – captcoma Jun 22 at 16:01

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