[Federal Register Volume 77, Number 244 (Wednesday, December 19, 2012)]
[Notices]
[Pages 75173-75174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-30511]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1202]


Comprehensive Assessment of the Process for the Review of Device 
Submissions; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the statement of work for an 
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 2013-2017. 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 will be conducted by an independent contractor in two 
phases. FDA is providing a period of 30 days for public comment on the 
statement of work before requesting proposals for the assessment.
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    \1\ http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM295454.pdf.

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DATES: Submit electronic or written comments by February 4, 2013.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document. All comments 
received may be posted without change to http://www.regulations.gov, 
including any personal information provided. For additional information 
on submitting comments, see the ``Comments'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.

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, [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).\2\ 
Title II of FDASIA is MDUFA III, which gives FDA the authority to 
collect device user fees from industry for fiscal years (FYs) 2013 to 
2017. MDUFA III took effect on October 1, 2012, and will sunset in 5 
years on October 1, 2017.
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    \2\ 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.

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

[[Page 75174]]

contract with FDA, 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. For 
Phase 1, FDA will award the contract no later than the end of the 
second quarter of FY2013. Findings on high-priority recommendations 
(i.e., those likely to have a significant impact on review times) will 
be published within 6 months of award; final comprehensive findings and 
recommendations will be published within 1 year of contract award. FDA 
will 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 will address FDA's premarket review process using an 
assessment framework that draws from appropriate quality system 
standards, including, but not limited to, management responsibility, 
document controls and records management, and corrective and preventive 
action.
    The assessment will include, but not be 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.
    FDA is seeking public comment now on the proposed statement of work 
for the assessment, available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/UCM331516.pdf.

III. Comments

    Interested persons may submit either written comments regarding the 
statement of work to the Division of Dockets Management (see ADDRESSES) 
or electronic comments to http://www.regulations.gov. It is only 
necessary to send one set of comments. Identify comments with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to 
the docket at http://www.regulations.gov.

    Dated: December 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30511 Filed 12-18-12; 8:45 am]
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