As of October 1, 2025, the U.S. Food and Drug Administration (FDA) has announced that it is not accepting new medical device submissions, FDA User Fee payments, or Small Business Determination applications. This temporary suspension applies to all types of medical device submissions, including premarket notifications (510(k)). This suspension may affect product launch timelines and business planning, so organizations should prepare for potential delays in regulatory processes.
PaxMed recommends that clients continue to utilize our professional services to develop and prepare your 510(k) submissions, even during the current government shutdown. Our experienced team remains fully operational, dedicated to advancing your projects without interruption. By continuing work on your 510(k), you can ensure your submission is ready for review as soon as normal FDA operations resume. Click on the link at the bottom of this web page or select the “Contact Us” web page to request more information from PaxMed.