[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\1\ http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM295454.pdf.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\2\ http://www.gpo.gov/fdsys/pkg/PLAW-112publ144/pdf/PLAW-112publ144.pdf.
---------------------------------------------------------------------------
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]
BILLING CODE 4160-01-P