MITA testifies at medical device user fee hearing

By AuntMinnie.com staff writers

March 29, 2017 -- The Medical Imaging and Technology Alliance (MITA) testified March 28 at a hearing on the Medical Device User Fee Act before the U.S. House of Representatives Committee on Energy and Commerce's subcommittee on health.

Diane Wurzburger, executive of regulatory affairs for GE Healthcare, testified on MITA's behalf, asking for reauthorization of the program, according to the alliance.

"If enacted, the [Medical Device User Fee Act] will improve [U.S. Food and Drug Administration (FDA)] review of medical devices, ensuring that American patients have timely access to these technologies," she said.

The act was negotiated between the FDA and the medical device industry last year and includes process changes that improve the predictability, consistency, transparency, and timeliness of the premarket review process, MITA said.


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