[Congressional Record (Bound Edition), Volume 148 (2002), Part 17]
[Senate]
[Pages 23143-23145]
[From the U.S. Government Publishing Office, www.gpo.gov]




PERFORMANCE GOALS FOR THE MEDICAL DEVICE USER FEE AND MODERNIZATION ACT 
                                OF 2002

  Mr. KENNEDY. Mr. President, on October 17, 2002, the Senate passed 
the

[[Page 23144]]

Medical Device User Fee and Modernization Act of 2002, ``MDUFMA''. 
Included in Title I of this bill is the authorization of medical device 
user fees.
  Performance goals, existing outside of the statute, accompany the 
authorization of medical device user fees. These goals represent a 
realistic projection of what the Food and Drug Administration's Center 
for Devices and Radiological Health and Center for Biologics Evaluation 
and Research can accomplish with industry cooperation. The Secretary of 
Health and Human Services forwarded these goals to the chairmen of the 
Committee on Energy and Commerce of the House of Representatives and 
the Committee on Health, Education, Labor and Pensions of the Senate, 
in a document entitled ``MDUFMA PERFORMANCE GOALS AND PROCEDURES.'' 
According to Section 101 of Title I of MDUFMA, ``the fees authorized by 
this title will be dedicated to meeting the goals set forth in the 
Congressional Record.''
  Today I am submitting for the Record this document, which was 
forwarded to the Committee on Health, Education, Labor and Pensions on 
November 14, 2002, as well as the letter from Secretary Thompson that 
accompanied the transmittal of this document.
  I ask unanimous consent to print those items.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                MDUFMA Performance Goals and Procedures

  The performance goals and procedures of the FDA Center for Devices 
and Radiological Health (CDRH) and the Center for Biologics Evaluation 
and Research (CBER), as agreed to under the medical device user fee 
program in the Medical Device User Fee and Modernization Act of 2002, 
are summarized as follows:

       I. REVIEW PERFORMANCE GOALS--FISCAL YEAR 2003 THROUGH 2007

       All references to ``days'' mean ``FDA days.''


 A. Original Premarket Approval (PMA), Panel-PMATrack Supplement, and 
                      Premarket Report Submissions

       1. The following cycle goals apply to: 75% of submission 
     received in fiscal year 2005; 80% of submissions received in 
     fiscal year 2006; 90% of submissions received in fiscal year 
     2007.
       (a) First action major deficiency letters will issue within 
     150 days.
       (b) All other first action letters (approval, approvable, 
     approvable pending good manufacturing practices (GMP) 
     inspection, not approvable, or denial) will issue within 180 
     days.
       (c) Second or later action major deficiency letters will 
     issue within 120 days.
       (d) Amendments containing a complete response to major 
     deficiency or not approvable letters will be acted on within 
     180 days.
       2. Decision Goals:
       (a) 80% of submissions received in fiscal year 2006 will 
     have an FDA decision in 320 days.
       (b) 90% of submissions received in fiscal year 2007 will 
     have an FDA decision in 320 days.
       3. Subject to the following paragraph, 50% of submissions 
     received in fiscal year 2007 will have an FDA decision in 180 
     days.
       This goal will be re-evaluated following the end of fiscal 
     year 2005. FDA will hold a public meeting to consult with its 
     stakeholders and to determine whether this goal is 
     appropriate for implementation in fiscal year 2007. If FDA 
     determines that the goal is not appropriate, prior to August 
     1, 2006, the Secretary will send a letter to the Committee on 
     Health, Education, Labor and pensions of the Senate and to 
     the Energy and Commerce Committee, Subcommittee on Health of 
     the House of Representatives stating that the goal will not 
     be implemented and the rationale for its removal.
       4. 90% of amendments containing a complete response to an 
     approvable letter received in fiscal years 2003 through 2007 
     will be acted on within 30 days.


                 B. Expedited Original PMA Submissions

       1. The following goals apply to PMA submissions where:
       (a) FDA has granted the application expedited status;
       (b) The applicant has requested and attended a pre-filing 
     review meeting with FDA;
       (c) The applicant's manufacturing facilities are prepared 
     for inspection upon submission of the application; and
       (d) The application is substantively complete, as defined 
     at the pre-filing review meeting.
       2. The following cycle goals apply to: 70% of submissions 
     received in fiscal year 2005; 80% of submissions received in 
     fiscal year 2006; 90% of submissions received in fiscal year 
     2007.
       (a) First action major deficiency letters will issue within 
     120 days.
       (b) All other first action letters (approval, approvable, 
     approvable pending GMP inspection, not approvable, or denial) 
     will issue within 170 days.
       (c) Second or later action major deficiency letters will 
     issue within 100 days.
       (d) Amendments containing a complete response to major 
     deficiency or not approvable letters will be acted on within 
     170 days.
       3. Decision Goals:
       (a) 70% of submissions received in fiscal year 2005 will 
     have an FDA decision in 300 days.
       (b) 80% of submissions received in fiscal year 2006 will 
     have an FDA decision in 300 days.
       (c) 90% of submissions received in fiscal year 2007 will 
     have an FDA decision in 300 days.
       4. 90% of amendments containing a complete response to an 
     approvable letter received in fiscal years 2003 through 2007 
     will be acted on within 30 days.


                  C 180-Day PMA Supplement Submissions

       1. The following goals apply to: 80% of submissions in 
     fiscal year 2005; 85% of submissions in fiscal year 2006; 90% 
     of submissions in fiscal year 2007.
       (a) First action not approvable letters will issue within 
     120 days.
       (b) All other first action letters (approval, approvable, 
     approvable pending GMP inspection, not approvable or denial) 
     will issue within 180 days.
       (c) Amendments containing a complete response to a not 
     approvable letter will be acted on within 160 days.
       2. Decision Goals:
       (a) 80% of submissions received in fiscal year 2005 will 
     have an FDA decision in 180 days.
       (b) 80% of submissions received in fiscal year 2006 will 
     have an FDA decision in 180 days.
       (c) 90% of submissions received in fiscal year 2007 will 
     have an FDA decision in 180 days.
       3. Current performance for real-time review PMA supplement 
     submissions will be maintained.


                         D. 510(k) Submissions

       1. The following goals apply to: 70% of submissions 
     received in fiscal year 2005; 80% of submissions received in 
     fiscal year 2006; 90% of submissions received in fiscal year 
     2007.
       (a) First action additional information letters will issue 
     within 75 days.
       (b) Subsequent action letters will issue within 60 days.
       2. Decision Goals:
       (a) 75% of submissions received in fiscal years 2005 and 
     2006 will have an FDA decision in 90 days.
       3. Subject to the following paragraph, 80% of submissions 
     received in fiscal year 2007 will have an FDA decision in 90 
     days.
       This goal will be re-evaluated following the end of fiscal 
     year 2005. FDA will hold a public meeting to consult with its 
     stakeholders and to determine whether this goal is 
     appropriate for implementation in fiscal year 2007. If FDA 
     determines that the goal is not appropriate, prior to August 
     1, 2006, the Secretary will send a letter to the Committee on 
     Health, Education, Labor and Pensions of the Senate and to 
     the Energy and Commerce Committee, Subcommittee on Health of 
     the House of Representatives stating that the goal will not 
     be implemented and the rationale for its removal, and that 
     the goal for fiscal year 2006 will be implemented for fiscal 
     year 2007.


          E. Original Biologics Licensing applications (BLAs)

       The following goals apply to: 75% of submissions received 
     in fiscal year 2006; 90% of submissions received in fiscal 
     year 2007.
       1. Review and act on standard original BLA submissions 
     within 10 months of receipt.
       2. Review and act on priority original BLA submissions 
     within 6 months of receipt.


                      F. BLA Efficacy Supplements

       The following goals apply to: 75% of submissions received 
     in fiscal year 2006; 90% of submissions received in fiscal 
     year 2007.
       1. Review and act on standard BLA efficacy supplement 
     submissions within 10 months of receipt.
       2. Review and act on priority BLA efficacy supplement 
     submissions within 6 months of receipt.


       G. Original BLA and BLA Efficacy Supplement Resubmissions

       The following goals apply to: 75% of submissions received 
     in fiscal year 2005; 80% of submissions received in fiscal 
     year 2006; 90% of submissions received in fiscal year 2007.
       1. Review and act on Class 1 original BLA and BLA efficacy 
     supplement resubmissions within 2 months of receipt.
       2. Review and act on Class 2 original BLA and BLA efficacy 
     supplement resubmissions within 6 months of receipt.


       H. BLA Manufacturing Supplements Requiring Prior Approval

       The following goal applies to: 75% of submissions received 
     in fiscal year 2006; 90% of submissions received in fiscal 
     year 2007.
       Review and act on BLA manufacturing supplements requiring 
     prior approval within 4 months of receipt.

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           I. Additional Efforts Related To Performance Goals

       The Agency and the regulated industry agree that the use of 
     both informal and formal meetings (e.g., determination and 
     agreement meetings, informal pre-investigational device 
     exemption (IDE) meetings, pre-PMA meetings, pre-PMA filing 
     meetings) by both parties is critical to ensure high 
     application quality such that the above performance goals can 
     be achieved.


                 j. maintenance of current performance

       It is the intent of the Agency that in review areas where 
     specific performance goals have not been identified, current 
     performance will be maintained.


                  k. application of user fee revenues

       The Agency intends to apply significant user fee revenues 
     to support reviewer training and hiring and/or outside 
     contracting to achieve the identified performance goals in a 
     responsible and efficient manner.


                     l. modular pma review program

       The Agency intends to issue guidance regarding the 
     implementation of new section 515(c)(3) of the Federal Food, 
     Drug, and Cosmetic Act. It is the intent of the Agency that 
     once this program is implemented, the Agency will work with 
     its stakeholders to develop appropriate performance goals for 
     this program. Until such time, the Agency intends to review 
     and close complete modules that are submitted well in advance 
     of the PMA submission as expeditiously as possible.


                   m. ``follow-on'' licensed devices

       The Center for Biologics Evaluation and Research will, if 
     feasible, identify a category of ``follow-on'' licensed 
     devices and collect information to determine whether 
     alternative performance goals for such a category are 
     appropriate.


                           n. bundling policy

       The Agency will, in consultation with its stakeholders, 
     consider the issue of bundling for products with multiple 
     related submissions. After such consultation, the Agency will 
     either issue guidance on bundling or publish a notice 
     explaining why it has determined that bundling is 
     inappropriate.


                  o. electronic review of applications

       The Agency will continue its efforts toward development of 
     electronic receipt and review of applications, as 
     expeditiously as possible, acknowledging that insufficient 
     funding is included in the user fee program for this effort.


                       p. preapproval inspections

       The Agency will plan to improve the scheduling and 
     timeliness of preapproval inspections. The Agency will 
     monitor the progress of these efforts and provide such 
     information in the annual performance report.

                     II. ANNUAL STAKEHOLDER MEETING

       Beginning in fiscal year 2004, FDA will hold annual public 
     meetings to review and evaluate the implementation of this 
     program in consultation with its stakeholders.

               III. DEFINITIONS AND EXPLANATION OF TERMS

       A. For original PMA submissions, Panel-Track PMA supplement 
     submissions, expedited original PMA submissions, 180-day 
     supplement submissions, and premarket report submissions, 
     issuance of one of the following letters is considered to be 
     an FDA decision:
       1. approval
       2. approvable
       3. approvable pending GMP inspection
       4. not approvable
       5. denial
       B. For 510(k) submissions, issuance of one of the following 
     letters is considered to be an FDA decision:
       1. substantially equivalent (SE)
       2. not substantially equivalent (NSE)
       C. Submission of an unsolicited major amendment to an 
     original PMA submission, Panel-Track PMA supplement 
     submission, expedited original PMA submission, 180-day 
     supplement submission, or premarket report submission extends 
     the FDA decision goal date by the number of days equal to 75% 
     of the difference between the filing date and the date of 
     receipt of the amendment. The submission of the unsolicited 
     major amendment is also considered an action that satisfies 
     the first or later action goal, as applicable.
       D. For BLA (original, efficacy supplement, or manufacturing 
     supplement) submissions, the term ``review and act on'' is 
     understood to mean the issuance of a complete action letter 
     after the complete review of a filed complete application. 
     The action letter, if it is not an approval, will set forth 
     in detail the specific deficiencies and, where appropriate, 
     the actions necessary to place the application in condition 
     for approval.
       E. For original BLA and BLA efficacy supplement 
     resubmissions:
       1. Class 1 resubmitted applications are applications 
     resubmitted after a complete response letter that include the 
     following items only (or combinations of these items):
       (a) Final printed labeling
       (b) Draft labeling
       (c) Safety updates submitted in the same format, including 
     tabulations, as the original safety submission with new data 
     and changes highlighted (except when large amounts of new 
     information including important new adverse experiences not 
     previously reported with the product are presented in the 
     resubmission)
       (d) Stability updates to support provisional or final 
     dating periods
       (e) Commitments to perform Phase 4 studies, including 
     proposals for such studies
       (f) Assay validation data
       (g) Final release testing on the last 1-2 lots used to 
     support approval
       (h) A minor reanalysis of data previously submitted to the 
     application (determined by the agency as fitting the Class 1 
     category)
       (i) Other minor clarifying information (determined by the 
     Agency as fitting the Class 1 category)
       (j) Other specific items may be added later as the Agency 
     gains experience with the scheme and will be communicated via 
     guidance documents to industry.
       2. Class 2 resubmissions are resubmissions that include any 
     other items, including any item that would require 
     presentation to an advisory committee.
                                       The Secretary of Health and


                                               Human Services,

                                Washington, DC, November 14, 2002.
     Hon. Edward Kennedy,
     U.S. Senate,
     Washington, DC.
       Dear Mr. Chairman. As you are aware, the Medical Device 
     User Fee and Modernization Act of 2002 was signed by the 
     President on October 26, 2002. Under Title I, the additional 
     revenues generated from fees paid by the medical device 
     industry will be used to expedite the medical device review 
     process, in accordance with performance goals that were 
     developed by the Food and Drug Administration (FDA) in 
     consultation with the industry.
       FDA has worked with various stakeholders, including 
     representatives from consumer, patient, and health provider 
     groups, and the medical device industry to develop 
     legislation and goals that would enhance the success of the 
     device review program. Title I of the Medical Device User Fee 
     and Modernization Act of 2002 reflects the fee mechanisms and 
     other improvements developed in these discussions. The 
     performance goals referenced in Section 101 are specified in 
     the enclosure to this letter, entitled ``Performance Goals 
     and Procedures.'' I believe they represent a realistic 
     projection of what FDA can accomplish with industry 
     cooperation and the additional resources identified in the 
     bill.
       This letter and the enclosed goals document pertain only to 
     title I (Fees Related to Medical Devices) of Public Law 107-
     250, Medical Device User Fee and Modernization Act of 2002. 
     OMB has advised that there is no objection to the 
     presentation of these views from the standpoint of the 
     Administration's program. We appreciate the support of you 
     and your staffs, the assistance of other Members of the 
     Committee, and that of the Appropriations Committees, in the 
     authorization of this vital program.
           Sincerely,
     Tommy G. Thompson.

                          ____________________