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:
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:
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.