Browse by topic
Subscribe to our news

FDA

3 Tips for Efficiently Preparing Your FDA eSTAR Submission

As part of the FDA Reauthorization Act (FDARA) and the Medical Device User Fee Amendments (MDUFA IV) of 2017, the U.S. Food and Drug Administration (FDA) committed to developing electronic submission templates. The intent of these templates is to provide guided submission preparation tools, improve submission consistency, and enhance efficiency in the review process. Since the commitment was announced, the FDA has issued guidance documents on electronic submissions for medical devices, developed the electronic Submission Template and Resource (eSTAR), and launched the voluntary eSTAR Program.
Read Now
1

We are passionate about your success. Tell us more about your regulatory and quality needs so we can help.

Book a Consultation

GLOBAL BOTTOM CTA INSTRUCTIONS:

To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!