Some 510k records with 'statement' value stored in the summary searchable field from openFDA do not have summary information from FDA database

Question

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?

Answer 1

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