Zdrowie i gospodarka · 27/02/2020

FDA Launches Voluntary Pilot Program to Improve 510(k) Submission Preparation and Review Process

The FDA is seeking public comments on its voluntary Electronic Submission Template and Resource (eSTAR) Pilot Program, which aims to enhance consistency and efficiency in the preparation and review of premarket notification (510(k)) submissions, and provide industry stakeholders with an opportunity to provide input on the eSTAR template and resources.