[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