[Federal Register Volume 81, Number 26 (Tuesday, February 9, 2016)]
[Page 6869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02545]

[[Page 6869]]



Food and Drug Administration

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

Independent Assessment of the Process for the Review of Device 
Submissions; Implementation Evaluation Report

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
Booz Allen Hamilton's final evaluation report submitted as part of 
their independent assessment of the process for the review of medical 
device submissions. The evaluation 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 
through 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 evaluation has been conducted as the second 
phase (Phase 2) and is the last of a series of deliverables, as 
outlined in the contract statement of work.

FOR FURTHER INFORMATION CONTACT: Raphaela Simon, Office of Planning, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 
3379, Silver Spring, MD 20993-0002, 301-796-9169, 


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 fiscal years 2013 through 2017. MDUFA III took effect 
on October 1, 2012, and will continue through September 30, 2017.

    \1\ https://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\ 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 the contract award and are 
included in the report available at www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM426392.pdf. FDA agreed to publish an 
implementation plan within 1 year of the final findings and 
recommendations. The final implementation plan, ``Plan of Action,'' was 
published December 2014 and is available at www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM426392.pdf. Examination of 
the final comprehensive findings and recommendations report led FDA to 
conclude that the recommendations could be expanded to further enhance 
the efficiency of premarket reviews. Those actions were also outlined 
in the Plan of Action. To distinguish actions in direct response to the 
recommendations from additional actions to further improve the 
premarket review process, FDA used a ``Stage'' approach. In the Plan of 
Action ``Stage 1'' actions directly addressed the recommendations in 
the independent assessment and ``Stage 2'' actions outlined additional 
long-term actions the Agency intended to implement to further enhance 
the premarket review process. In addition, FDA has publicly stated in 
the ``Plan of Action'' that the Agency intended to complete all Stage 1 
actions by December 31, 2015.

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

    For Phase 2 of the independent assessment, the contractor evaluated 
the implementation of recommendations, described under Stage 1 in the 
``Plan of Action,'' and is publishing its written assessment \4\ no 
later than February 1, 2016.

    \4\ http://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM484146.pdf.

    FDA has implemented all Stage 1 actions outlined in the Plan of 
Action, and incorporated the resulting enhancements into the management 
of the premarket review program. Resources permitting, the Center for 
Devices and Radiological Health will continue to implement Stage 2 
actions. FDA will monitor implemented improvements for accomplishment 
of intended results and the process for the review of device 
submissions for additional improvement opportunities.

    Dated: February 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02545 Filed 2-8-16; 8:45 am]