FDA eSTAR Template has changed 10 things

How to prepare an FDA eSTAR 510(k) submissionПодробнее

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

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

eSTAR 5.0 - Are You Ready?Подробнее

What is the difference between a 510k and De Novo?Подробнее

FDA eSTAR Draft Guidance Document released September 29, 2021Подробнее

Finally FDA CDRH releases an FDA eSTAR draft guidance for the eSTAR 510(k) templatesПодробнее

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

Health Canada Pilot with the FDA eSTAR templateПодробнее

FDA's 510(k) Modernization: What if Anything has Changed? Is Changing? Will Change?Подробнее

Worried about Your Next FDA Meeting? Key Tips to Make It a SuccessПодробнее

RTA Hold and AI Request Responses to an FDA 510(k) ReviewerПодробнее

Four things the e-STAR template teaches us about digitalizationПодробнее

Consensus Standards Webinar for the FDA eSTAR (Mar 14)Подробнее

eSTAR: What You Need to KnowПодробнее

510(k) Tip - Update your User Manual template to include all labeling elements in the FDA eSTARПодробнее

What 7 FDA eSTAR requirements are missing from your IFU?Подробнее

Software Validation Documentation for Medical Devices - FDA eSTARПодробнее