[Federal Register Volume 78, Number 239 (Thursday, December 12, 2013)]
[Notices]
[Pages 75571-75572]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-29612]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1504]


Independent Assessment of the Process for the Review of Device 
Submissions; High Priority Recommendations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is presenting Booz 
Allen Hamilton's high priority 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 2013 
to 2017. The assessment is described in section V, ``Independent 
Assessment of Review Process Management'', of the commitment letter 
entitled ``MDUFA Performance Goals and Procedures'' \1\ (MDUFA III 
Commitment Letter). The assessment is being conducted in two phases. 
The high priority recommendations are the first of a series of 
deliverables, as outlined in the contract statement of work,\2\ to be 
published as part of Phase 1 of the assessment.
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    \1\ www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM295454.pdf.
    \2\ http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/ucm314036.htm.

FOR FURTHER INFORMATION CONTACT: Amber Sligar, Office of Planning, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 3291, 
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Silver Spring, MD 20993-0002, 301-796-9384, [email protected].

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).\3\ 
Title

[[Page 75572]]

II of FDASIA is MDUFA III, which gives FDA the authority to collect 
device user fees from industry for fiscal years 2013 to 2017. MDUFA III 
took effect on October 1, 2012, and will continue through September 30, 
2017.
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    \3\ http://www.gpo.gov/fdsys/pkg/PLAW-112publ144/pdf/PLAW-112publ144.pdf.
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    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.\4\
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    \4\ www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM295454.pdf.
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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 scheduled to 
be published within 6 months of award and are included in the report 
available through the link near the end of this notice. Final 
comprehensive findings and recommendations are scheduled to be 
published within 1 year of contract award. FDA agreed to publish an 
implementation plan within 6 months of receipt of each set of 
recommendations. 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:
    1. Identification of process improvements and best practices for 
conducting predictable, efficient, and consistent premarket reviews 
that meet regulatory review standards.
    2. Analysis of elements of the review process (including the 
presubmission 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, companion diagnostic products, and laboratory developed tests 
on the review process.
    3. Assessment of FDA methods and controls for collecting and 
reporting information on premarket review process resource use and 
performance.
    4. Assessment of effectiveness of FDA's Reviewer Training Program 
implementation.
    5. 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. 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 findings on high priority recommendations 
are available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/ucm314036.htm.

    Dated: December 6, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-29612 Filed 12-6-13; 8:45 am]
BILLING CODE 4160-01-P