Regulatory Blog

The U.S. Food and Drug Administration (FDA) has issued a draft guidance titled “Electronic Submission Template for Investigational Device Exemption (IDE) Applications” to support sponsors submitting IDE applications to the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). The October 2026 draft guidance introduces the electronic Submission Template and Resource (eSTAR) as the current electronic submission template f