FDA Database: PMA vs Product Code vs CLIA-FDA

FDA databases give you overlapping but distinct views into device approval.

Here's the basic homepage for a PMA device, the IDYLLA (Biocartis) MSI CDx test:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=P250005

You get the device, the applicant, the P-number (P250005), the time under review (2/25 to 8/25), the product code (SFL), the approval order (labeling).

But you can also get the CLIA view from the FDA, which adds a header section that repeats the test system name and specialty (PATHOLOGY), and the CLIA Complexity level (HIGH).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Detail.cfm?ID=41847

Click on the product classification:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=5488

Click on the SSED (Summary of Data), 45 pp.

https://www.accessdata.fda.gov/cdrh_docs/pdf25/P250005B.pdf

"Labeling" is the full instructions for use, here, 50pp:

https://www.accessdata.fda.gov/cdrh_docs/pdf25/P250005D.pdf

The Approval Order is a short letter, here, 4pp, but sometimes give you information like postmarket required studies which is found only here.

https://www.accessdata.fda.gov/cdrh_docs/pdf25/P250005A.pdf

e.g.,