Investigational Device Exemption (IDE): Regulatory & Clinical Trial Support An Investigational Device Exemption (IDE) enables sponsors to conduct clinical studies of medical devices to collect essential safety and effectiveness data before FDA approval. IDE submissions require detailed regulatory strategy, IRB approval, risk classification, and strict compliance oversight. bioaccess®, based in Miami, FL, provides expert CRO support to guide sponsors through the IDE process, streamline study execution, and accelerate medical device development with regulatory confidence and operational excellence. Visit us: https://www.bioaccessla.com/