2014-12403. Independent Assessment of the Process for the Review of Device Submissions; Final Comprehensive Findings and Recommendations and First Implementation Plan

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing Booz Allen Hamilton's final comprehensive findings and recommendations submitted as part of their 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 entitled “MDUFA Performance Goals and Procedures” (MDUFA III Commitment Letter). The assessment is being conducted in two phases. The final comprehensive findings and recommendations are the last of a series of deliverables, as outlined in the contract statement of work, to be published as part of Phase 1 of the assessment.

FOR FURTHER INFORMATION CONTACT:

Amber Sligar, Office of Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 3291, Silver Spring, MD 20993-0002, 301-796-9384, [e-mail].

SUPPLEMENTARY INFORMATION:

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 awarded the contract 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 in December 2013.^[3] Final comprehensive findings and recommendations were scheduled to be published within 1 year of contract award and are included in the report available at http://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​Overview/​MDUFAIII/​ucm314036.htm. FDA agreed to publish an implementation plan within 6 months of receipt of each set of recommendations. The first of these implementation plans has been completed and is also available at http://www.fda.gov/​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.

The assessment includes, but is not limited to, the following areas:

• Identification of process improvements and best practices for conducting predictable, efficient, and consistent premarket reviews that meet regulatory review standards.
• Analysis of elements of the review process (including the Pre-Submission process, and investigational device exemption, premarket notification (510(k)), and premarket approval application reviews) that consume or save time to facilitate a more efficient process. This includes analysis of root causes for inefficiencies that may affect review performance and total time to decision. This will also include recommended actions to correct any failures to meet MDUFA goals. Analysis of the review process will include the impact of combination products and companion diagnostic products on the review process.
• Assessment of FDA methods and controls for collecting and reporting information on premarket review process resource use and performance.
• Assessment of effectiveness of FDA's Device Reviewer Training Program implementation.
• Recommendations for ongoing periodic assessments and any additional, more detailed or focused assessments.

FDA will incorporate findings and recommendations, 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.

The contractor's Phase 1 final comprehensive findings and recommendations along with FDA's implementation plan based on the contractor's high-priority recommendations issued December 11, 2013, are available at http://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​Overview/​MDUFAIII/​ucm314036.htm.

Dated: May 22, 2014.

Leslie Kux,

Assistant Commissioner for Policy.

Footnotes

1.  http://www.gpo.gov/​fdsys/​pkg/​PLAW-112publ144/​pdf/​PLAW-112publ144.pdf.

2.  http://www.fda.gov/​downloads/​MedicalDevices/​NewsEvents/​WorkshopsConferences/​UCM295454.pdf.

3.  http://www.fda.gov/​downloads/​MedicalDevices/​DeviceRegulationandGuidance/​Overview/​MDUFAIII/​UCM378202.pdf.