[Federal Register Volume 79, Number 103 (Thursday, May 29, 2014)]
[Pages 30853-30854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-12403]



Food and Drug Administration

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

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, [email protected].


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.

    \1\ 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.\2\

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

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 
    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.

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

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

[[Page 30854]]

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.
[FR Doc. 2014-12403 Filed 5-28-14; 8:45 am]