[Federal Register Volume 79, Number 245 (Monday, December 22, 2014)]
[Pages 76333-76334]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29800]



Food and Drug Administration

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

Independent Assessment of the Process for the Review of Device 
Submissions; Final Implementation Plan

AGENCY: Food and Drug Administration, HHS.

[[Page 76334]]

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability on FDA's Web site of the Agency's final implementation 
plan published as part of Booz Allen Hamilton's 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 dated April 18, 2012, and 
entitled ``MDUFA Performance Goals and Procedures'' (MDUFA III 
Commitment Letter). The assessment is being conducted in two phases. 
The final implementation plan is FDA's response to Booz Allen 
Hamilton's comprehensive findings and recommendations and the final 
deliverable resulting from the first phase of the assessment.

FOR FURTHER INFORMATION CONTACT: Amber Sligar, Office of Planning, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3372, 
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 will incorporate findings and recommendations from the 
assessment, 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 ongoing 
training of FDA staff, and periodic audits of compliance with the 
    FDA awarded the contract for the independent assessment 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 December 11, 2013.\3\ Final 
comprehensive findings and recommendations were published June 11, 
2014.\4\ FDA agreed to publish an implementation plan within 6 months 
of receipt of each set of recommendations. The first of these 
implementation plans was published June 11, 2014.\5\ The second and 
final implementation plan is 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.
    \4\ http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/UCM400676.pdf.
    \5\ http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/UCM400674.pdf.

    FDA's implementation plan based on the contractor's final findings 
and recommendations (issued June 11, 2014) is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/ucm314036.htm.

    Dated: December 16, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29800 Filed 12-19-14; 8:45 am]