Heidi Alexander: “I ask unanimous consent to have printed in the Record a copy of the commitment letter for the Medical Device User Fee…”

“I ask unanimous consent to have printed in the Record a copy of the commitment letter for the Medical Device User Fee Amendments of 2017. There being no objection, the material was ordered to be printed in the Record, as follows: MDUFA Performance Goals and Procedures, Fiscal Years 2018 Through 2022 General The performance goals and procedures agreed to by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) of the United States Food and Drug Administration (``FDA'' or ``the Agency'') for the medical device user fee program in the Medical Device User Fee Amendments of 2017, are summarized below. FDA and the industry are committed to protecting and promoting public health by providing timely access to safe and effective medical devices. Nothing in this letter precludes the Agency from protecting the public health by exercising its authority to provide a reasonable assurance of the safety and effectiveness of medical devices. Both FDA and the industry are committed to the spirit and intent of the goals described in this letter. I. SHARED OUTCOME GOALS The program and initiatives outlined in this document are predicated on significant interaction between the Agency and applicants.…”