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Independent Assessment of the Process for the Review of Device Submissions; Final Implementation Plan

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Food and Drug Administration, HHS.

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The Food and Drug Administration (FDA) is announcing the availability on FDA's Web site of the Agency's final implementation plan published as part of Booz Allen Hamilton's independent assessment of the process for the review of medical device submissions. The assessment is part of the FDA performance commitments relating to the Medical Device User Fee Amendments of 2012 (MDUFA III), which reauthorized device user fees for fiscal years (FYs) 2013-2017. The assessment is described in section V, Independent Assessment of Review Process Management, of the commitment letter dated April 18, 2012, and entitled “MDUFA Performance Goals and Procedures” (MDUFA III Commitment Letter). The assessment is being conducted in two phases. The final implementation plan is FDA's response to Booz Allen Hamilton's comprehensive findings and recommendations and the final deliverable resulting from the first phase of the assessment.

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Amber Sligar, Office of Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3372, Silver Spring, MD 20993-0002, 301-796-9384,

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I. Background

On July 9, 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) (FDASIA).[1] Title II of FDASIA is the Medical Device User Fee Amendments of 2012 (MDUFA III), which gives FDA the authority to collect device user fees from industry for FYs 2013-2017. MDUFA III took effect on October 1, 2012, and will continue through September 30, 2017.

Device user fees were first established by Congress in 2002. Medical device companies pay fees to FDA when they register their establishment and list their devices with the Agency, whenever they submit an application or a notification to market a new medical device in the United States, and for certain other types of submissions. Under MDUFA III, FDA is authorized to collect user fees that will total approximately $595 million (plus adjustments for inflation) over 5 years. With this additional funding, FDA will be able to hire more than 200 full-time-equivalent workers over the course of MDUFA III. In exchange, FDA has committed to meet certain performance goals outlined in the MDUFA III Commitment Letter.[2]

II. Assessment of FDA's Process for the Review of Device Submissions

Section V of the MDUFA III Commitment Letter states that FDA and the device industry will participate in a comprehensive assessment of the process for the review of device applications. The assessment will include consultation with both FDA and industry. The assessment will be conducted in two phases by a private, independent consulting firm, under contract with FDA, that is capable of performing the technical analysis, management assessment, and program evaluation tasks required to address the assessment as described in the MDUFA III Commitment Letter.

FDA will incorporate findings and recommendations from the assessment, as appropriate, into its management of the premarket review program. FDA will analyze the recommendations for improvement opportunities identified in the assessment, develop and implement a corrective action plan, and assure its effectiveness. FDA also will incorporate the results of the assessment into a Good Review Management Practices (GRMP) guidance document for medical devices. FDA's implementation of the GRMP guidance will include initial and ongoing training of FDA staff, and periodic audits of compliance with the guidance.

FDA awarded the contract for the independent assessment in June 2013 to the consulting firm Booz Allen Hamilton. Findings on high-priority recommendations (i.e., those likely to have a significant impact on review times) were published December 11, 2013.[3] Final comprehensive findings and recommendations were published June 11, 2014.[4] FDA agreed to publish an implementation plan within 6 months of receipt of each set of recommendations. The first of these implementation plans was published June 11, 2014.[5] The second and final implementation plan is available at​MedicalDevices/​DeviceRegulationandGuidance/​Overview/​MDUFAIII/​ucm314036.htm. For Phase 2 of the independent assessment, the contractor will evaluate the implementation of recommendations and publish a written assessment no later than February 1, 2016.

FDA's implementation plan based on the contractor's final findings and recommendations (issued June 11, 2014) is available at​MedicalDevices/​DeviceRegulationandGuidance/​Overview/​MDUFAIII/​ucm314036.htm.

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Dated: December 16, 2014.

Leslie Kux,

Associate Commissioner for Policy.

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[FR Doc. 2014-29800 Filed 12-19-14; 8:45 am]