Echo Therapeutics Inc. (ECTE) announced it has submitted a pre-submission package to the U.S. FDA for the Symphony CGM System for use in the hospital critical care environment. The company has requested a meeting with the FDA to work cooperatively on the clinical and regulatory plan to support FDA approval of the System.
Echo Therapeutics submitted the pre-submission documentation to the FDA to obtain guidance regarding the U.S. regulatory pathway for Symphony, the proper approach to refining the pivotal trial protocol and endpoints, and preparing the pre-marketing application.
The FDA's Pre-Submission Program is intended to allow applicants the opportunity to obtain targeted FDA feedback in response to specific questions related to product development.
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