Using the new eSTAR templates for a 510(k) submission and the FDA eSTAR draft guidance

Using the new eSTAR templates for a 510(k) submission and the FDA eSTAR draft guidance

How to Prepare a Medical Device 510k Submission for FDAПодробнее

How to Prepare a Medical Device 510k Submission for FDA

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

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

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

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

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

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

Finally FDA CDRH releases an FDA eSTAR draft guidance for the eSTAR 510(k) templatesПодробнее

Finally FDA CDRH releases an FDA eSTAR draft guidance for the eSTAR 510(k) templates

How to prepare an FDA eSTAR 510(k) submissionПодробнее

How to prepare an FDA eSTAR 510(k) submission

FDA eSTAR Draft Guidance Document released September 29, 2021Подробнее

FDA eSTAR Draft Guidance Document released September 29, 2021