Using the new eSTAR templates for a 510(k) submission and the FDA eSTAR draft guidance

eSTAR: What You Need to KnowПодробнее

Now you can upload an FDA eSTAR or eCopy using the FDA Customer Collaboration Portal (CCP)Подробнее

510(k) eSTAR Webinar - Indications for Use and ClassificationПодробнее

FDA eSTAR - General Info - #1 in the 510(k) eSTAR seriesПодробнее

Finally FDA CDRH releases an FDA eSTAR draft guidance for the eSTAR 510(k) templatesПодробнее

How to prepare an FDA eSTAR 510(k) submissionПодробнее

FDA eSTAR Draft Guidance Document released September 29, 2021Подробнее