2012-30511. 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.

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, [e-mail].

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.

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 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.

Footnotes

1.  http://www.fda.gov/​downloads/​MedicalDevices/​NewsEvents/​WorkshopsConferences/​UCM295454.pdf.

2.  http://www.gpo.gov/​fdsys/​pkg/​PLAW-112publ144/​pdf/​PLAW-112publ144.pdf.