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I see there is a searchable field called 'summary_or_statement' from openFDA API to indicate the summary or statement result. However, some records with "statement' value for the summary_or_statement don't have summary links from FDA database. Where could we find the related summary documents?

2 Answers 2

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There may be instances where that value is not filled in - in these cases, you can cross-reference from our upstream data source, which is also publicly available. That data is located here: https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances

Regards,

Violet Wren

openFDA Tech Lead

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I think the question was what into do if the openFDA database indicates a summary_or_statement that is then not available from the FDA 510(k) database.

I had the same issue: enter image description here 510(k) summary documents indicated on openFDA are not available from FDA 510(k) database

I think in many old cases with a missing PDF/file link there is most likely no electronic copy available. In this case, the file could probably be recovered via a Freedom of Information Act request (FOIA).

In newer cases it could just be a missing PDF/file link and the FDA might just update the entry.

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