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I am seeking to understand the source of data discrepancies between the openFDA API and the FDA database.

For example I am using the following query to find all records that match a PMA submission number:

https://api.fda.gov/device/udi.json?limit=10&search=premarket_submissions.submission_number:P230013

All 9 responses have a supplement number of 000.

When I search for the same PMA number on the FDA Database site I see three supplement numbers: 001, 002 and 003.

My use case requires aligning these two data sources. Is this discrepancy to be expected? If so is there a reason that the two are not aligned?

Thank you for making this data available - it is a huge help to my team. I appreciate any insights you can provide.

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openFDA derives its UDI endpoint from an UDI data file supplied to us from within the FDA. The supplement number of 000 comes directly from that data file and thus makes it into openFDA as well. For example, you can see that 000 is indeed shown on Device GUDID pages, such as here.

Unfortunately, we do not have any insight that would explain the discrepancy between the UDI dataset and PMI dataset at this time. However, you could try contacting FDA CDRH directly and asking for an explanation.

Thank you for using openFDA.

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