The Office of Management and Budget (OMB) has cleared a commitment letter between the medical device industry and the U.S. Food and Drug Administration (FDA), bringing the reauthorization of the medical device user fee program closer to implementation, the Medical Imaging and Technology Alliance (MITA) said.
The negotiated agreement includes additional provisions to improve device review through added transparency and predictability, according to MITA. It contains new goals for total review time for premarket reviews; establishes protocols for earlier, more effective communications between manufacturers and the FDA; and calls for an independent, third-party audit of the premarket review program.
"Together, these program improvements create a more predictable and productive process that will insure that patients have access to safe and effective technologies in a timely manner," MITA said in a statement.
The FDA is expected to publish the agreement in the Federal Register for a 30-day public comment period, after which it will officially offer the package to Congress for legislative approval, according to MITA.
