Medical technologists -- welcome to the world of "non-binding advice."
The U.S. Food and Drug Administration plans to provide medical device makers feedback before they apply for marketing approval to help companies identify regulatory requirements early in the device development process.
The new program, called "Pre-Sub," is in response to a MDUFMA that increases fees in return for more meetings.
"FDA's early feedback on studies can facilitate the development of a quality premarket submission and help industry avoid regulatory hurdles during the review process," said Christy Foreman, director of the Office of Device Evaluation in FDA's Center for Devices and Radiological Health (CDRH).
The FDA is seeking public comment on the Pre-Sub draft guidance.
