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Have you thought about including redacted copies of 510(k) submissions available from the CDRH FOIA Electronic Reading Room [1]? You could probably just provide
by akehrer 10y ago
Have you thought about including redacted copies of 510(k) submissions available from the CDRH FOIA Electronic Reading Room [1]? You could probably just provide a list of links to the PDFs.
Here's an example of one for a powered laser surgical instrument (warning: 57MB PDF):
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHFOIAElectronicReadingRoom/UCM249906.pdf http://www.fda.gov/downloads/AboutFDA/CentersOffices/Officeo...
[1] http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/readingroom.cfm http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/read...
- bkolko 10y agoWe had downloaded several 510(k)s early in our process, but found them so heavily redacted that they didn't really give the overview we needed. That's why we worked so hard to redact as little as possible in our own docs. I'll dig deeper into that set of links to see if there are some that have more info in them. Thanks!