I downloaded the PMA devices dataset from here https://download.open.fda.gov/device/pma/device-pma-0001-of-0001.json.zip

However, It seems like the denied filings were not included since the decision_code field only reports the following strings: APCB APCV APPR APRL APWD OK30

If this is the case, is it possible to access the denied filings too?

1 Answer 1


openFDA generates the content of the Device PMA dataset from the PMA/PDP downloadable file made available by the FDA. The decision codes you have mentioned cover all the codes contained in that file, which is also why openFDA would not have the denied filings information.

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