Using the openfda API, is there a way to download the 510(k) summary documents using the API? Or simple get the links to those summaries?

Question

I can use the API to determine if a "statement_or_summary" exists. Is there a way to download the 510(k) summary documents, or get links to those documents? I am fine ignoring the documents that are missing summaries.

Answer 1

openFDA does not contain the actual summary or statement documents. You can determine which results have summary or statement results with the following query: https://api.fda.gov/device/510k.json?search=statement_or_summary:Summary+OR+statement_or_summary:Statement

I don't see anywhere on the FDA's 510(k) website regarding a download location for Summaries or Statements, so you may want to follow up with the FDA directly.

Regards,

Violet Wren, openFDA Tech Lead