[Congressional Record Volume 153, Number 148 (Tuesday, October 2, 2007)]
[Senate]
[Pages S12420-S12421]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




  PERFORMANCE GOALS FOR THE MEDICAL DEVICE USER FEE AMENDMENTS OF 2007

  Mr. KENNEDY. Mr. President, on September 20, 2007, the Senate passed 
H.R. 3580, the Food and Drug Administration Amendments Act of 2007. 
Title II of this bill includes the reauthorization of the FDA's medical 
device user fee program.
  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 ``MDUFA PERFORMANCE GOALS AND PROCEDURES.'' 
According to Section 201(c) of H.R. 3580, ``the fees authorized under 
the amendments made by this title will be dedicated toward expediting 
the process for the review of device applications and for assuring the 
safety and effectiveness of devices, as set forth in the goals . . . in 
the letters from the Secretary of Health and Human Services to the 
Chairman of the Committee on Health, Education, Labor, and Pensions of 
the Senate and the Chairman of the Committee on Energy and Commerce of 
the House of Representatives, as 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 
September 27, 2007, as well as the letter from Secretary Leavitt that 
accompanied the transmittal of this document.
  I ask unanimous consent this material be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                                    Health and

                                               Human Services,

                               Washington, DC, September 27, 2007.
     Edward M. Kennedy,
     Chairman, Committee on Health, Education, Labor, and 
         Pensions, U.S. Senate, Washington, DC.
       Dear Chairman Kennedy: I want to congratulate you for 
     completing action on the FDA Amendments Act, H.R. 3580. As 
     you know, this bill contains the reauthorization of user fees 
     for drugs and devices as well as other key provisions vital 
     to the Food and Drug Administration. We appreciate your 
     support and hard work on this legislation, the commitment of 
     Members of the Committee in working out these measures, and 
     the support shown by the full Senate.
       I am including as enclosures to this letter the two 
     commitment documents for the drug and device user fee 
     programs which outline the agreements between the Agency and 
     the industries with regard to application approval 
     timeframes, issuance of guidances, post market program 
     enhancements, and milestones for other activities to be 
     supported by user fees. These documents cover fiscal years 
     2008 through 2012 and they represent the commitment of the 
     Department and the FDA to carry out the goals under the 
     mutual agreement with the industries.
       Thank you again for successful enactment of the FDA 
     Amendments Act. I look forward to working with you as we 
     proceed with the implementation of this legislation.
           Sincerely,
                                               Michael O. Leavitt,
     Secretary.
                                  ____


                 MDUFA 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 Amendments of 2007, are summarized as follows:
       I. Review performance goals--Fiscal year 2008 through 2012 
     as applied to receipt cohorts.
       All references to ``days'' mean ``FDA days.''
       A. Original premarket approval (PMA), panel-track PMA 
     supplement, and premarket report submissions.
       FDA will issue a decision for 60 percent of non-expedited 
     filed submissions within 180 days, and for 90 percent within 
     295 days.
       B. Expedited original PMA and panel-track PMA supplement 
     submissions.
       FDA will issue a decision for 50 percent of expedited filed 
     submissions within 180 days, and for 90 percent within 280 
     days.
       C. PMA modules.
       FDA will take action on 75 percent of PMA modules within 90 
     days, and on 90 percent within 120 days.
       D. 180-day PMA supplements.
       FDA will issue a decision for 85 percent of 180-day PMA 
     supplements within 180 days, and for 95 percent within 210 
     days.
       E. Real-time PMA supplements.
       FDA will issue a decision for 80 percent of real-time PMA 
     supplements within 60 days, and for 90 percent within 90 
     days.
       F. 510(k) submissions.
       FDA will issue a decision for 90 percent of 510(k)s within 
     90 days, and for 98 percent within 150 days.
       G. Maintenance of current performance.
       The agency will, at a minimum, maintain current review 
     performance in review areas such as IDEs and 30-day Notices 
     where specific quantitative goals have not been established.
       H. Interactive review.
       The agency will continue to incorporate an interactive 
     review process to provide for, and encourage, informal 
     communication between FDA and sponsors to facilitate timely 
     completion of the review process based on accurate and 
     complete information. Interactive review entails 
     responsibilities for both FDA and sponsors.
       Interactive review is intended to: (a) prevent unnecessary 
     delays in the completion of the review; (b) avoid surprises 
     to the sponsor at the end of the review process; (c) minimize 
     the number of review cycles and extent of review questions 
     conveyed through formal requests for additional information; 
     and (d) ensure timely responses from sponsors.
       All forms of communication should be used as ``tools'' to 
     facilitate interactive review. These include, but are not 
     limited to, the following: (a) e-mail; (b) one-on-one 
     telephone calls; (c) telephone conferences; (d) 
     videoconferencing; (e) fax; and (f) face-to-face meetings.
       Application of these tools for interactive review should 
     remain flexible, balancing speed and efficiency with the need 
     to ensure supervisory concurrence for significant information 
     requests. In general, e-mail should be the preferred 
     mechanism for informal communication because it creates a 
     clear record of the interaction, with telephone calls used 
     primarily for seeking clarification or answers to very 
     limited questions. Conferencing, either by telephone, video, 
     or face-to-face mechanisms, should be used at key milestones, 
     such as those described below, in the review process.
       A cornerstone of interactive review is that communication 
     should occur as needed to facilitate a timely and efficient 
     review process. In particular:
       1. There should be regular, informal communication from FDA 
     to seek clarification on issues that can be resolved without 
     substantive review or analysis. When appropriate, FDA will 
     also informally communicate substantive review issues if FDA 
     determines that it will facilitate a timely and efficient 
     review process.
       Because all reviewers will be active participants in the 
     interactive review process established under this agreement, 
     it should be a natural outcome that reviewers will share 
     issues with sponsors prior to incorporating them into 
     formal letters.
       2. Whenever FDA informally requests additional information, 
     the sponsor and FDA will determine an acceptable timeframe 
     for submission of the information. If the information is not 
     received within the agreed upon

[[Page S12421]]

     timeframe or the information is incomplete, the application 
     will be placed on hold (with a major deficiency letter or AI 
     letter) until the information is received.
       FDA will develop a guidance document that incorporates 
     these general principles and should make them operational 
     within the review processes for 510(k)s, PMAs, and PMA 
     supplements. FDA will use this detailed interactive review 
     summary as the basis for a guidance document which FDA will 
     issue as a ``final'' guidance 6 months from the date an 
     agreed upon legislative package is sent to Congress or 3 
     months from the date of enactment, whichever is later.
       I. Meetings.
       FDA will make every effort to schedule both informal and 
     formal meetings, both before and during the review process, 
     in a timely manner and industry will make every effort to 
     provide timely and relevant information to make the meetings 
     as productive as possible. These meetings include, but are 
     not limited to the following: pre-submission meetings, 
     determination meetings, agreement meetings, and Day-100 
     meetings (for PMAs).
       J. Quarterly performance reports.
       The agency will report quarterly its progress toward 
     meeting the quantitative goals described in this letter and 
     will do so in a timely manner. In addition, for all 
     submission types, FDA will track total time (time with FDA 
     plus time with the company) from receipt or filing to final 
     decision for approval, denial, SE, or NSE. FDA will also 
     provide de-identified review performance data for the branch 
     with the shortest average review times and the branch with 
     the longest average review times for 510(k)s, 180-day 
     supplements, and real-time supplements on an annual basis. 
     Finally, in an effort to enhance accountability and 
     transparency, the agency will meet with the industry 
     informally on a semi-annual basis to discuss issues related 
     to performance and expenditures. At that time, the agency 
     will provide a qualitative update on how funding is being 
     used for the device review process, including investments in 
     information technology and training.
       K. New commitments.
       All agency guidance documents will reflect commitments made 
     in this goals letter, as appropriate. If a guidance document 
     has not been updated, FDA will still act in accordance with 
     the goals letter.
       L. Reviewer training.
       As resources permit, the agency will apply user fee 
     revenues to support reviewer training that is related to the 
     process for the review of devices, including training to 
     enhance scientific expertise. FDA will provide summary 
     information on the types of training provided to its staff on 
     an annual basis.
       M. Guidance document development.
       The agency will continue to develop guidance documents to 
     the extent possible without adversely impacting the 
     timeliness of review of MDUFA-related submissions. Each year, 
     FDA will post a list of guidance documents it is considering 
     for development and provide stakeholders an opportunity to 
     provide comments and/or draft language for those topics as 
     well as suggestions for new or different guidances.
       N. Imaging devices with contrast agents or 
     radiopharmaceuticals.
       FDA will, after consultation with affected parties, develop 
     a guidance document intended to ensure timely and effective 
     review of, and consistent and appropriate postmarket 
     regulation and labeling recommendations for, diagnostic 
     imaging devices used with imaging contrast agents and/or 
     radiopharmaceuticals approved for the same or different 
     indications. Draft guidance will be published by the end of 
     FY 2008, and will be subject to a 90-day public comment 
     period. FDA will issue a final guidance within one year of 
     the close of the public comment period.
       O. In vitro diagnostics.
       To facilitate the development of in vitro diagnostic (IVD) 
     devices, FDA will continue to explore ways to clarify the 
     regulatory requirements and reduce regulatory burden, as 
     appropriate, by:
       1. Issuing new or revised guidance on: (a) the conduct of 
     clinical trials involving de-identified leftover specimens; 
     (b) clinical trial design issues for molecular diagnostic 
     tests; (c) migration studies; (d) Herpes Simplex Virus IVDs; 
     (e) enterovirus IVDs; and (f) influenza testing.
       2. Conducting a pilot program to evaluate integrating the 
     510(k) review and Clinical Laboratory Improvement Amendments 
     (CLIA) waiver review processes for possible increased 
     efficiencies. This pilot will include only voluntary 
     participants from industry, and the 510(k) applications 
     involved in the pilot will not be counted toward the MDUFA 
     performance goals.
       3. Considering industry proposals on acceptable CLIA waiver 
     study protocols, developing acceptable protocol designs, and 
     making them available by adding appendices to the CLIA waiver 
     guidance or by posting redacted protocols on the FDA website.
       4. Tracking review times for CLIA waiver applications, 
     sharing this information with industry annually and, at the 
     end of year two of MDUFA, evaluating whether CLIA waiver user 
     fees and performance goals should be considered for MDUFA 
     III.
       5. Reviewing a list of class I and II low risk IVD devices, 
     to be provided by industry, to determine whether any of them 
     could be exempted from premarket notification, and allowing 
     interested parties to petition for exemptions consistent with 
     section 510(m)(2) of the Federal Food, Drug, and Cosmetic Act 
     (the Act).
       6. Performing a review of its pre-IDE program for IVD 
     devices. This review will be conducted during the first year 
     of MDUFA and will focus on specific issues identified by 
     industry that they would like to see addressed by the program 
     review.
       P. Transition period.
       FDA will meet the performance goals established under MDUFA 
     II beginning October 1, 2007. However, because, beginning 
     October 1, 2007, FDA will be reviewing submissions under 
     MDUFMA I goals and MDUFA II goals at the same time (due to 
     submissions received in FY 2007 but acted upon in FY 2008), 
     FDA will not manage to the MDUFMA I cycle goals for those 
     submissions received in fiscal year 2007. FDA will meet the 
     MDUFMA I decision goals for submissions received in FY07 and 
     will apply the principles of interactive review.
       II. Definitions and explanations of terms.
       A. FDA Decision.
       PMA decisions are approval, approvable, approvable pending 
     GMP inspection, not approvable, withdrawal, and denial. 
     510(k) decisions are substantially equivalent (SE) or not 
     substantially equivalent (NSE).
       Not Approvable decisions will generally not be issued on 
     the first review cycle. The rare cases where a not approvable 
     decision might be issued on the first review cycle would 
     include situations such as (1) the application is complete 
     and there are no outstanding FDA issues, but the data do not 
     demonstrate that the device provides reasonable assurance of 
     safety and effectiveness, or (2) the PMA receives a not 
     approvable recommendation from an advisory panel. Any ``Not 
     Approvable'' decision will be accompanied by the rationale 
     for its issuance.
       Submission of an unsolicited major amendment to any 
     original PMA, premarket report, panel-track supplement, or 
     180-day supplement extends the FDA decision goal date by the 
     number of days equal to 75 percent of the difference between 
     the filing date and the date of receipt of the amendment.
       B. Expedited review.
       The MDUFA II expedited review performance goals will apply 
     only to devices for which expedited review has been granted 
     in accordance with section 515(d)(5) of the Act.
       If in any one fiscal year, the number of submissions 
     granted expedited review equals 10 or more, FDA will be held 
     to the expedited review performance goals for that fiscal 
     year.
       If in any one fiscal year, the number of submissions 
     granted expedited review is less than 10, then it is 
     acceptable to combine the submissions for the following 
     year(s) in order to form a cohort of 10 submissions upon 
     which FDA will be held to the performance goals. However, FDA 
     will continue to report performance data on the cohort for 
     each fiscal year.
       C. PMA modules.
       Action on a PMA module includes accepting the module, 
     request for additional information, receipt of the PMA, and 
     withdrawal of the module.
       D. 180-day PMA supplements.
       Decisions for 180-day PMA supplements include approval, 
     approvable, approvable pending GMP inspection, and not 
     approvable.
       FDA will implement a major deficiency letter process for 
     180-Day PMA Supplements (similar to that for PMAs).
       E. Real-time PMA supplements.
       Decisions for real-time PMA supplements include approval, 
     approvable, and not approvable.

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