FDA eSTAR Program for Medical Device Submissions

FDA eSTAR Program for Medical Device Submissions

The National Customs Brokers and Freight Forwarders Association (NCBFAA) recently released a notice regarding the new FDA eSTAR program for medical device submissions. Here’s what we know: 

The Food and Drug Administration (FDA) recently released information about their new eSTAR Program which allows companies to voluntarily submit their medical devices for Pre-Market Approval (PMA) for: 

• Original PMAs
• PMA Panel Track Supplements 
• PMA Real-Time Supplements 
• PMA 180-Day Supplements 

The FDA is using the eSTAR program to help improve the efficiency of the medical device review process. Here are some of the benefits listed for the new program: 

• The interactive PDF ensures applicants fill out the necessary information. 
• Provides a standardized format to make the information accessible. 
• Auto-fills information already entered, to avoid entering information multiple times. 
• Built-in database to ensure information is relevant and auto-filled accurately. 
• Built-in forms, so users don’t have to search for them. 
• Collects data in a structured format to help automate aspects of FDA processing. 
• Serves as a comprehensive resource to consolidate necessary information and links needed for submission. 

We encourage all importers of medical devices to utilize as many of FDA’s on-line tools as possible. Please contact your Western Overseas representative for further information.