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FDA / openfda

openFDA is a research project to provide open APIs, raw data downloads, documentation and examples, and a developer community for an important collection of FDA public datasets.
https://open.fda.gov
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Get predicate device for given 510(k) clearance #200

Open fumoboy007 opened 6 months ago

fumoboy007 commented 6 months ago

A device can be “cleared” by the FDA by demonstrating that it is “substantially equivalent” to a “predicate device”, which is a previously cleared or approved device. Does the current API support getting the predicate device for a given 510(k) clearance?

dkrylovsb commented 6 months ago

Not at this time, unfortunately.

fumoboy007 commented 6 months ago

Thanks for confirming, @dkrylovsb! This GitHub issue is a feature request then. 😊

wcedmisten commented 4 months ago

@fumoboy007 I've been scraping PDFs from the FDA's website and using OCR to find the predicates. This approach is not 100% accurate, so an official source would be better, but if you need this information, check out my repo:

https://github.com/wcedmisten/fda-510k-analysis

I also made a website for searching this info if it's helpful: 510k.fyi

Let me know if you have any questions!