Using the api for the 510(k) database in openfda, I can search the statement_or_summary field and find all the rows (i.e. devices) with summaries. But in the download, the api just produces the string "Summary" in that field. In the actual FDA database, that string includes a hyperlink to a pdf document in FDA's database that is the actual "Summary." I want to download the actual links so I can consult the summary itself. How do I download the links to the pdf documents. Those summaries are rich in information.
1 Answer
openFDA gets its 510(k) data from the 510(k) downloadable files made available by the FDA. As described on the File Layout for Releasable 510(k)s page, statement_or_summary contains either "SUMMARY" or "STATEMENT". SUMMARY indicates that a summary of safety and effectiveness information is available from FDA. STATEMENT indicates that safety and effectiveness information may be obtained from the 510(k) applicant.
It appears the hyperlink you're looking for is missing from the downloadable 510(k) files and therefore is unavailable in openFDA as well. Unfortunately, at this point you would have to look for other resources to obtain the said hyperlink. Sorry about the inconvenience.
answered Aug 27, 2020 at 15:36
statement_or_summaryreturns 'Summary' but there are a lot of missing entries on the part of the FDA.