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FY 2008 MDUFA Performance Report

 Printable version


Table of Contents

Commissioner’s Report

Executive Summary

Overview of MDUFMA I and MDUFA II

MDUFMA I (FY 2003 through FY 2007)

MDUFA II (FY 2008 through FY 2012) 

FY 2008 Activities and Accomplishments

Total Review Times 

Report on MDUFMA I Goals

Performance for MDUFMA I Decision Goals for FY 2003 through FY 2006

Transition Period (FY 2007)

Report on FY 2008 MDUFA II Goals

MDUFA II Performance At-A-Glance for FY 2008

Original PMAs, Panel-Track PMA Supplements, and Premarket Reports

Expedited Original PMAs and Panel-Track PMA Supplements 

PMA Modules

180-Day PMA Supplements

Real-Time PMA Supplements

510(k) Premarket Notifications

Report on Additional MDUFA II Performance Commitments

Maintenance of Current Performance

Interactive Review

Biologics Applications Review Performance for FY 2008

Meetings

Quarterly Performance Reports 

Reviewer Training

Guidance Document Development

Imaging Devices with Contrast Agents or Radiopharmaceuticals

In Vitro Diagnostics

Appendix

Appendix A:September 27, 2007, Commitment Letter from HHS Secretary to Congress

Footnotes


Commissioner’s Report

The enactment of the Medical Device User Fee Amendments of 2007 (MDUFA II) reauthorizes medical device user fees for fiscal year (FY) 2008 through FY 2012. Medical device user fees were first authorized in 2002 under the Medical Device User Fee Modernization Act (MDUFMA I), and have provided the Food and Drug Administration (FDA) an important source of additional resources that have allowed us to pursue an ambitious set of negotiated performance goals. This report is our sixth report on medical device user fee review performance, and the first to reflect the revised, better-focused, and more-demanding goals set under MDUFA II. I am pleased to report that we have met or exceeded most of our agreed on review time goals during this first year under the new goals, while leaving some opportunity for further improvement.

 

MDUFA II requires close collaboration with stakeholders and effective communication with applicants. FDA has successfully implemented an innovative interactive review process as a key means of ensuring that we focus on our negotiated performance goals, while never losing sight of our ultimate objective: to ensure that there is reasonable assurance that medical devices marketed in the United States are safe and effective. The agency is continually working to clarify our regulatory requirements, and seeking to make our decisions transparent through new guidance, educational materials, and meetings. FDA has worked hard to improve the efficiency and flexibility of our review processes. These efforts help applicants improve the quality of their submissions, help FDA provide more timely, better-focused reviews, and help make important new medical devices available to patients and healthcare providers earlier.

 

I am proud of the progress FDA has made in meeting the challenges and responsibilities provided by MDUFMA I and now MDUFA II. The results we have achieved, and the long-term objectives we continue to pursue, demonstrate the value of medical device user fees and the parallel negotiated performance goals to FDA, to the medical device industry, and, particularly, to patients and healthcare professionals.

Margaret A. Hamburg, M.D.

Commissioner of Food and Drugs

 


Executive Summary

MDUFMA I amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize FDA to collect user fees from manufacturers who submit certain applications and reports to FDA. MDUFA II reauthorized these fees and added several additional fees, including fees from persons who register certain establishments. In parallel with this authority, FDA, industry, and Congress negotiated and agreed to a comprehensive set of review performance goals and commitments that seek to improve the timeliness and predictability of medical device reviews from FY 2008 through FY 2012. MDUFA II builds on the progress made under MDUFMA I and, like MDUFMA I, requires FDA to submit an annual report to Congress concerning its progress in achieving these goals and outlining its future plans for meeting the goals. This report satisfies that requirement.

 

During FY 2008, FDA continued to make progress in meeting its negotiated performance goals. FDA worked with stakeholders to improve communication and understanding of MDUFA II’s requirements and to ensure that its implementation accomplishes MDUFA II objectives. The performance gains and improved predictability in review processes achieved under MDUFA II and MDUFMA I should provide significant benefits to industry, healthcare professionals, and patients.

 

While this report focuses primarily on FY 2008 under MDUFA II, FDA is also providing updated information on MDUFMA I performance for the FY 2003 through FY 2007 receipt cohorts.

 

FY 2008 Highlights

FDA continued to focus on consulting with its stakeholders, developing guidance documents, and designing and building the new review processes required to meet MDUFA II’s challenging performance goals. Among the key areas addressed during FY 2008 were:

  • Implementation of new performance goals for FY 2008 through FY 2012. FDA modified its business processes to effectively pursue and meet the new performance goals, and implementation of an interactive review program was a particularly significant accomplishment.
  • Guidance to industry. FDA issued six guidance documents to explain and implement aspects of the MDUFA II program, including one required by statute and three to meet requirements of the FDA Commitment Letter.
  • Stakeholder communication and consultation. During FY 2008, FDA’s consultations with stakeholders focused on implementation of medical device user fees and performance goals for FY 2008 through FY 2012.
  • Overall performance. FDA’s preliminary performance on the FY 2008 receipt cohort indicates FDA is meeting or exceeding review times for actions completed on most performance goals (excluding the goals for PMA module reviews).

 


Overview of MDUFMA I and MDUFA II

Like MDUFMA I, the goal of MDUFA II is to better serve the public health by providing additional funds to FDA for “the process for the review of devices and the assurance of device safety and effectiveness so that statutorily mandated deadlines may be met.” The additional funding provided by MDUFA II will be used to promote the following significant benefits:

  • Safe and effective medical devices will reach patients more rapidly.
  • Manufacturers will receive timely, high quality reviews with greater consistency.
  • Resources will be provided to ensure that devices marketed in the United States continue to meet high standards for safety and effectiveness.

 

MDUFMA I (FY 2003 through FY 2007)

On October 26, 2002, MDUFMA I was signed into law.[1] MDUFMA I amended the FD&C Act authorizing FDA to collect fees from companies who submit certain applications for marketing of medical devices. In return, MDUFMA I required FDA to pursue a comprehensive set of device review performance goals that were intended to significantly improve the timeliness and predictability of FDA’s review of new devices. Few goals were applied during FY 2003 and FY 2004, allowing FDA time to hire staff, build infrastructure, provide guidance to industry, and take other actions. Consequently, most substantive review performance goals went into effect in FY 2005. Additional goals were added in FY 2006 and again in FY 2007, with the goals becoming more demanding each year.

 

On April 1, 2004, MDUFMA I was amended and expanded by the Medical Device Technical Corrections Act (MDTCA), Public Law (P.L.) 108-214. MDTCA amended MDUFMA I to clarify Congress’ intent and to improve and expand upon some features of MDUFMA I. On August 1, 2005, the Medical Device User Fee Stabilization Act of 2005 (the “Stabilization Act”), P.L. 109-43, amended provisions of the FD&C Act relating to medical device user fees and device labeling; however, these changes did not affect the performance goals FDA was pursuing under MDUFMA I.

 

FDA will continue to work to meet MDUFMA I decision goals for submissions received in FY 2007 and prior years. However, FDA will no longer apply, track, or report on MDUFMA I first-action and subsequent-action cycle goals.
 

MDUFA II (FY 2008 through FY 2012)

On September 27, 2007, the President signed the FDA Amendments Act of 2007 (FDAAA), which included MDUFA II. MDUFA II reauthorized medical device user fees and identified new performance goals for FY 2008 through FY 2012.[2] MDUFA II committed FDA to meeting new premarket review performance goals, which are defined in the Department of Health and Human Services (HHS) Secretary’s September 27, 2007, letter to Congress.[3] The new performance goals focus on FDA decisions, because FDA decisions are so strongly linked to the final approval or clearance of new devices. These performance goals were developed with input from industry and were a key part of the negotiated package of user fees and other changes made by MDUFA II.

 

In addition to reauthorizing FDA to collect user fees for medical device applications, MDUFA II requires FDA to meet rigorous goals for reviewing medical devices that build on the progress of MDUFMA I. These goals are intended to achieve progressive, year-by-year improvements in review processes for medical devices. The majority of devices associated with MDUFA II are reviewed by the Center for Devices and Radiological Health (CDRH). However, a number of devices that are critical to ensuring the safety, purity, and potency of biologic products, including assuring the safety of our Nation’s supply of blood and human tissue products, are reviewed by the Center for Biologics Evaluation and Research (CBER). CBER also regulates diagnostic tests for retroviruses, including human immunodeficiency virus, as well as devices used in cell and gene therapies. An Intercenter Agreement between CBER and CDRH discusses the types of devices regulated by CBER and is available at: http://www.fda.gov/oc/ombudsman/bio-dev.htm.

 

MDUFA II requires the HHS Secretary to submit two annual reports to Congress: 1) a performance report, due within 120 days of the end of the fiscal year and 2) a financial report, due within 120 days of the end of the fiscal year. This report is FDA’s sixth annual performance report on its progress in achieving user fee performance goals and additional commitments, and covers actions through FY 2008. The current and past performance and financial reports are available at: http://www.fda.gov/oc/mdufma.

 

FY 2008 Activities and Accomplishments

During FY 2008, FDA focused on implementing and reporting on the new performance goals under MDUFA II. Specifically, FDA consulted with its stakeholders, developed guidance documents, and built the new review processes required to meet MDUFA II’s progressively challenging performance goals. Among the key activities and accomplishments during FY 2008 were:

 

  • Implementation of new performance goals for FY 2008 through FY 2012. As part of the reauthorization of medical device user fees, FDA agreed to a new set of challenging performance goals for FY 2008 through FY 2012. FDA modified its business processes to effectively pursue and meet the new goals, and implementation of an interactive review program during FY 2008 was a particularly significant accomplishment.
  • Progress in meeting MDUFA II performance goals for FY 2008 through FY 2012. As of September 30, 2008, all workload cohorts for FY 2008 remained open with preliminary performance results for the FY 2008 receipt cohort indicating FDA is meeting or exceeding most MDUFA II performance goals [excluding the goals for Premarket Approval Application (PMA) module reviews].[4] FDA’s performance on PMA modules for the FY 2008 receipt cohort has not met expectations. With the exception of PMA modules, these preliminary performance results may change as additional FDA decisions are made on the FY 2008 receipt cohorts.
  • Development of Guidance Documents. FDA issued six guidance documents that relate to MDUFA II and its performance goals and commitments for FY 2008 through FY 2012.
  • Draft Guidance for Humanitarian Device Exemption Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers. This guidance was required by section 303(c) of FDAAA and is available at: http://www.fda.gov/cdrh/ode/guidance/1668.pdf.
  • Guidance for Industry, FDA, and Foreign Governments: FY 2009 Medical Device User Fee Small Business Qualification and Certification available at: http://www.fda.gov/cdrh/mdufma/guidance/2009.pdf.
  • Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals available at:  http://www.fda.gov/cdrh/mdufma/guidance/1218.pdf.
  • Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original Biologics License Applications (BLAs), and BLA Supplements available at: http://www.fda.gov/cdrh/ode/guidance/1655.pdf.
  • Draft Guidance for Industry and FDA Staff: Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses available at: http://www.fda.gov/cdrh/oivd/guidance/1638.pdf.
  • Draft Guidance for Industry: New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products available at: http://www.fda.gov/oc/combination/contrastimg.pdf.
  • Stakeholder communication and consultation. During FY 2008, FDA’s consultations with stakeholders focused on reauthorization of medical device user fees and performance goals for FY 2008 through FY 2012.

 

Total Review Times

Beginning with the FY 2009 MDUFA Performance Report, FDA will provide summary review statistics on the total time required to render an FDA final decision, measured in elapsed days from receipt (or filing, for applications subject to filing) to FDA’s final decision. The summary review statistics will include industry time, and provide an indication of how well FDA and industry are doing in their mutual goal of seeing that reasonably safe and effective medical devices reach patients and healthcare professionals as rapidly as is consistent with an efficient and effective review process. FDA will update the data for each cohort in subsequent reports until each cohort is complete (meaning there is an FDA final decision, or an applicant withdrawal, for each application in the cohort).

 


Report on MDUFMA I Goals

FDA will continue to report on MDUFMA I decision goals for FY 2003 through FY 2006 cohorts under MDUFMA I until each cohort is closed. Additionally, FDA will report on MDUFMA I performance goals for FY 2007 decision cohorts during the transition period under MDUFA II. The following information refers to FDA performance presented in this section.

  • The word “cohort” refers to a MDUFMA I fiscal year cohort.
  • MDUFMA I review performance statistics are based on a receipt cohort. This methodology calculates performance statistics for the fiscal year submissions that were received, regardless of when FDA acted on the submissions. A result of this approach is that the statistics shown for a particular fiscal year may be subject to updates from one report to the next. As time passes, FDA continues to act on submissions within a fiscal year cohort. As more submissions are completed, the statistics for that fiscal year of receipt are updated to reflect completed actions.
  • Until all submissions in a cohort receive a final decision, a preliminary performance assessment will be provided for that cohort.
  • Performance tables indicate if the fiscal year cohort is closed to represent all actions completed with a “Y” for yes and an “N” for no.
  • All references to days mean FDA days. FDA days are the number of days FDA reviewed the document, not counting time periods where an application was on hold waiting on additional information requested from the sponsor.
  • All performance data in this report reflects FDA actions completed through September 30, 2008, unless otherwise specified.

 


Performance for MDUFMA I Decision Goals for FY 2003 through FY 2006

The table below presents FDA’s performance on the MDUFMA I decision goals for FY 2003 through FY 2006. Once a complete fiscal year cohort is reported as closed, FDA will not repeat this information in future annual user fee performance reports. The BLAs, BLA supplements, and resubmitted BLAs and BLA efficacy supplements were reported as closed for FY 2003 through FY 2006 cohorts in the FY 2007 MDUFMA Performance Report. Therefore, FDA will not report on these cohorts again. As of September 30, 2008, the FY 2003 cohort for PMAs, panel-track supplements, and premarket reports; expedited PMAs; 180-day PMA supplements; and 510(k)s are closed. Therefore, this is the final year for reporting on the FY 2003 cohort.

 

GoalsReview WithinFiscal YearCohort ClosedReceived*

Number on

Time / Actions Completed

Percent on TimePerformance Goal
PMAs, Panel-Track Supplements, and Premarket Reports
Make an “FDA decision”320 days2003Y5045 / 5090%No Goal
2004Y4844† / 4892%No Goal
2005N57†49 / 5589%No Goal
2006N5643 / 5381%80%
Expedited PMAs
Make an “FDA decision”300 days2003Y33 / 3100%No Goal
2004N1412 / 1392%No Goal
2005Y65 / 683%70%
2006N21 / 1100%80%
180-day PMA Supplements
Make an “FDA decision”180 days2003Y204192 / 20494%No Goal
2004Y106101 / 10695%No Goal
2005Y             10196 / 101             95%80%
2006N137†131 / 13597%80%
510(k)s
Make a “substantially equivalent” (SE) or “not substantially equivalent” (NSE) decision90 days2003Y3,7952,887 / 3,79576%No Goal
2004Y3,3812,835 / 3,38184%No Goal
2005N3,4023,100 / 3,40191%75%
2006N3,5073,198 / 3,49991%75%

* The data shown for 510(k)s represents the MDUFMA cohort.

† Numbers were updated to reflect corrections to the FY 2007 MDUFMA Performance Report.

 

Transition Period (FY 2007)

As of October 1, 2007, FDA reviewed submissions under MDUFMA I goals and MDUFA II goals at the same time (due to submissions received in FY 2007 but acted on in FY 2008). FY 2007 is being treated as a transition period from MDUFMA I to MDUFA II. FDA will continue to report on MDUFMA I decision goals for submissions received in FY 2007 and acted on in future fiscal years. Once the decision goals are reported closed, FDA will not repeat them in future annual user fee performance reports. The FY 2007 decision goals for priority original BLAs, standard and priority BLA efficacy supplements, and resubmitted BLAs and BLA efficacy supplements were closed in the previously published FY 2007 MDUFMA Performance Report and, therefore, are not reported in this FY 2008 report.

 


MDUFMA I 
FY 03FY 04FY 05FY 06FY 07FY 08FY 09FY 10FY 11FY 12
 TransitionMDUFA II

 

 

Performance for FY 2007

The tables below present updated performance for FY 2007 decision cohorts subject to MDUFMA I goals where the cohorts were reported open as of September 30, 2007, in the FY 2007 MDUFMA Performance Report. As of September 30, 2008, FDA issued decisions for over three-fourths (29 of 37) of PMAs, panel-track PMA supplements, and premarket reports. With submissions still pending action and not overdue, it is too early to make a final performance determination for PMAs, panel-track PMA supplements, and premarket reports. While one submission is pending action and not overdue for expedited PMAs, completing this action on time will not raise the overall performance sufficiently to meet the MDUFMA I performance goal in FY 2007.

 

GoalsReview WithinCohort ClosedReceived

Number on

Time / Actions Completed

Percent on TimePerformance Goal
PMAs, Panel-Track Supplements, and Premarket Reports
Make an “FDA decision”180 daysN37*17 / 2959%50%
320 daysN37*28 / 2997%90%
Expedited PMAs
Make an “FDA decision”300 daysN20 / 10%90%
* Numbers were updated to reflect corrections to the FY 2007 MDUFMA Performance Report.

 

With one submission pending action for 180-day PMA supplements, FDA exceeded the MDUFMA I performance goal in FY 2007. With almost all (3,200 of 3,271) 510(k) premarket notifications pending action, FDA will meet or exceed the MDUFMA I performance goal in FY 2007. FDA exceeded the MDUFMA I performance goals for BLAs and BLA supplements in FY 2007.

 

GoalsReview WithinCohort ClosedReceived*

Number on

Time / Actions Completed

Percent on TimePerformance Goal
180-day PMA Supplements
Make an “FDA decision”180 daysN142†130 / 14192%90%
510(k)s
Make a SE or NSE decision90 daysN3,2712,928 / 3,20092%80%
BLAs
Review and act on standard original BLAs6 monthsY22 / 2100%90%
BLA Supplements
Review and act on BLA manufacturing supplements that require prior approval (issue “complete action” letter)4 monthsY149†148 / 14999%90%

* The data shown for 510(k)s represents the MDUFMA cohort.

  Numbers were updated to reflect corrections to the FY 2007 MDUFMA Performance Report.

 


Report on FY 2008 MDUFA II Goals

This section presents FDA’s preliminary performance on MDUFA II performance goals and commitments for FY 2008. The following information refers to FDA performance presented in this section.

  • The word “cohort” refers to a MDUFA II fiscal year cohort.
  • MDUFA II review performance statistics are based on a receipt cohort.
  • Until all submissions in a cohort receive a final decision, a preliminary performance assessment will be provided for that cohort.
  • Performance tables indicate if the fiscal year cohort is closed with a “Y” for yes and an “N” for no.
  • All references to days mean FDA days. FDA days are the number of days FDA reviewed the document, not counting time periods where an application was on hold waiting on additional information requested from the sponsor.
  • All performance data in this report reflects FDA actions completed through September 30, 2008, unless otherwise specified.

 

Performance goals. MDUFA II focuses on making a timely FDA decision, as defined for each type of application. The cycle goals for first actions and subsequent actions that applied under MDUFMA I (during FY 2003 through FY 2007) have not been renewed and were not extended for FY 2008 and later years. Under the new approach adopted under MDUFA II, each performance goal consists of two tiers, each with a distinct review time target and a target performance level. Tier 1 goals focus on completing a significant proportion of reviews within tight time frames. The Tier 2 goals focus on completing the majority of reviews (90 percent to 98 percent, depending on the type of application involved) within somewhat longer time frames. For example, for PMAs and Panel-Track PMA Supplements, the goals for the FY 2008 through FY 2012 cohorts are:

Tier 1 - FDA will make a decision [approval, approvable, approvable pending current good manufacturing practice (GMP) inspection, not approvable, withdrawal, or denial] on 60 percent of applications within 180 days.

Tier 2 - FDA will make a decision on 90 percent of applications within 295 days.

 

Use of the two-tier approach helps ensure that a substantial proportion of reviews are completed quickly (Tier 1 goals), while also ensuring that FDA does not focus only on a select subset of applications. To meet the Tier 2 goals, FDA focuses on the entire cohort.

 

Measuring performance. MDUFA II performance goals (Tier 1 and Tier 2 decision goals) are quantifiable; that is, progress can be measured and described through standard statistics.

 

MDUFA II Performance At-A-Glance for FY 2008

A preliminary performance assessment of FY 2008 submissions subject to MDUFA II goals and acted on as of September 30, 2008, indicates that FDA was meeting review time goals for most MDUFA II performance goals (see table below).

 

"Graph Description"

 


Original PMAs, Panel-Track PMA Supplements, and Premarket Reports

 

Goals

The table below summarizes the annual review time goals for original PMAs, panel-track PMA supplements, and premarket reports.

GoalReview Time Goal

Performance Level

FY 2008 – FY 2012 Submissions

Issue a decision for non-expedited

filed submissions

180 days60% on time
295 days90% on time

  

Workload

The number of PMA, panel-track PMA supplement, and premarket report submissions decreased by 34 percent in FY 2007 and fell again, but at a lower rate (by 16 percent) in FY 2008,  reaching a 5-year low (see corresponding graph and table).

 "Graph Description"

PMAs, Panel-Track PMA Supplements, and Premarket Reports

TypeFY 04FY 05FY 06FY 07FY 08

Submissions

(PMAs / Panel-track PMA Supplements)

48

(40/8)

57*

(46/11)

56

(40/16)

37*

(33/4)

31†

 

* FY 2005 and FY 2007 numbers were updated to reflect corrections to the FY 2007 MDUFMA Performance Report.

† Due to system design changes for reporting under MDUFA II in FY 2008, FDA will no longer separate and report the submission types.

 

Performance for FY 2008

As of September 30, 2008, FDA issued decisions for almost one-fifth (6 of 31) of non-expedited filed submissions with all having met the review time goals (see table below). With submissions still pending action and not overdue, it is too early to make a final performance determination in FY 2008.

GoalsReview WithinCohort ClosedReceived

Number on

Time / Actions Completed

Percent on TimePerformance Goal

Issue a decision for

non-expedited filed submissions

180 daysN316 / 6100%60%
295 daysN316 / 6100%90%

 


Expedited Original PMAs and Panel-Track PMA Supplements

 

Goals

The table below summarizes the annual review time goals for expedited original PMAs and panel-track PMA supplements.

 

GoalReview Time Goal

Performance Level

FY 2008 – FY 2012 Submissions

Issue a decision for expedited

filed submissions

180 days50% on time
280 days90% on time

  

Workload

The number of expedited PMA and panel-track PMA supplement submissions increased in FY 2008, representing the first increase over the last 4 years (see corresponding graph and table).  

"Graph Description"

Expedited PMAs and Panel-Track PMA Supplements

TypeFY 04FY 05FY 06FY 07FY 08
Submissions*146224
* Only workload for expedited PMAs was reported on from FY 2004 through FY 2007. Workload for expedited panel-track PMA supplements was not reported during this time and not required under MDUFMA I. 

 

Performance for FY 2008

 With all expedited filed submissions still pending action and not overdue, it is too early to make a final performance determination for FY 2008 (see table below).

GoalsReview WithinCohort ClosedReceived

Number on

Time / Actions Completed

Percent on TimePerformance Goal
Issue a decision for expedited filed submissions180 daysN40 / 0n/a50%
280 daysN40 / 0n/a90%

 


PMA Modules

 

Goals

The table below summarizes the annual review time goals for PMA modules.[5] PMA modules are discrete sections of the PMA that can be submitted and reviewed independently. As a new PMA module is received or a change is submitted to a previously received module, a review cycle and review clock are started. The fiscal year cohort includes all new review cycles with a start date within a fiscal year. Until all cycles started in a fiscal year have been acted on, the fiscal year cohort remains open. Review time goals are the same for all review cycles.

 

Goal

Cycle Review

Time Goal

Performance Level

FY 2008 – FY 2012 Submissions

Take action on PMA module cycles90 days75% on time
120 days90% on time

  

Workload

In FY 2008, 43 PMA modules were either started or restarted (see corresponding graph and table). These 43 modules accounted for 54 cycles being started.  

"Graph Description"

PMA Modules

TypeFY 04*FY 05*FY 06*FY 07*FY 08
Modules Started or Restarted--------43
Cycles Started--------54
 * Workload for PMA modules was not reported under MDUFMA I.

 

Performance for FY 2008

As of September 30, 2008, FDA acted on almost three-fifths (32 of 54) of PMA module cycles with more than half having met the 90-day review time goal and all but four having met the 120-day review time goal (see table below). FDA will not meet the Tier 1 review performance goals for FY 2008 even with PMA modules still pending action and not overdue.

GoalsReview WithinCohort ClosedCycles Started

Number on

Time / Actions Completed

Percent on TimePerformance Goal
Take action on PMA module cycles90 daysN5417 / 3253%75%
120 daysN5428 / 3288%90%

180-Day PMA Supplements

 

Goals

The table below summarizes the annual review time goals for 180-day PMA supplements.

GoalReview Time Goal

Performance Level

FY 2008 – FY 2012 Submissions

Issue a decision for 180-day PMA supplements180 days85% on time
210 days95% on time

 

Workload

The number of 180-day PMA supplements submitted in FY 2008 increased by 78 percent from FY 2007. This represented the highest level in 5 years, and the third straight year of increases (see corresponding graph and table). 

"Graph Description"

180-Day PMA Supplements

TypeFY 04FY 05FY 06FY 07FY 08
Submissions106101137*142*253
* FY 2006 and FY 2007 numbers were updated to reflect corrections to the FY 2007 MDUFMA Performance Report.

 

Performance for FY 2008

As of September 30, 2008, FDA issued decisions for over four-fifths (208 of 253) of 180-day PMA supplements with all but 11 having met the 180-day review time goal and all but 2 having met the 210-day review time goal (see table below). With submissions still pending action and not overdue, it is too early to make a final performance determination for FY 2008.

GoalsReview WithinCohort ClosedReceived

Number on

Time / Actions Completed

Percent on TimePerformance Goal
Issue a decision for 180-day PMA supplements180 daysN253197 / 20895%85%
210 daysN253206 / 20899%95%

Real-Time PMA Supplements

 

Goals

 

The table below summarizes the annual review time goals for real-time PMA supplements.

GoalReview Time Goal

Performance Level

FY 2008 – FY 2012 Submissions

Issue a decision for real-time PMA supplements60 days80% on time
90 days90% on time

  

Workload

In FY 2008, 171 real-time PMA supplement submissions were received (see corresponding graph and table).  

 

"Graph Description"

 

 

 

Real-Time PMA Supplements

TypeFY 04*FY 05*FY 06*FY 07*FY 08
Submissions--------171
* Workload for real-time PMA supplements was not reported under MDUFMA I.

 

Performance for FY 2008

As of September 30, 2008, FDA issued decisions for over one-third (61 of 171) real-time PMA supplement submissions with all but three having met the 60-day review time goal and all but one having met the 90-day review time goal (see table below). With submissions still pending action and not overdue, it is too early to make a final performance determination for FY 2008.

GoalsReview WithinCohort ClosedReceived

Number on

Time / Actions Completed

Percent on TimePerformance Goal
Issue a decision for real-time PMA supplements60 daysN17158 / 6195%80%
90 daysN17160 / 6198%90%

510(k) Premarket Notifications

 

Goals

The table below summarizes the annual review time goals for 510(k) submissions.

GoalReview Time Goal

Performance Level

FY 2008 – FY 2012 Submissions

Issue a decision for 510(k)s90 days90% on time
150 days98% on time

  

Workload

The number of 510(k) submissions received in FY 2008 increased, returning close to the FY 2006 level. The MDUFA cohort portion of submissions also increased in FY 2008 and reached a 5-year high, representing 94 percent of all submissions (see corresponding graph and table).[6]

"Graph Description"

 

 

510(k) Premarket Notifications

TypeFY 04FY 05FY 06FY 07FY 08
Submissions3,7103,7133,9133,714*3,902
MDUFA Cohort3,3813,4023,5073,2713,686
* FY 2007 number was updated to reflect a correction to the FY 2007 MDUFMA Performance Report.

 

Performance for FY 2008

As of September 30, 2008, FDA issued decisions for three-fifths (2,197 of 3,686) of 510(k) submissions with most (2,146 of 2,197) having met the 90-day review time goal and almost all (2,194 of 2,197) having met the 150-day review time goal (see table below). With submissions still pending action and not overdue, it is too early to make a final performance determination for FY 2008.

GoalsReview WithinCohort ClosedReceived

Number on

Time / Actions Completed

Percent on TimePerformance Goal
Issue a decision for 510(k)s90 daysN3,6862,146 / 2,19798%90%
150 daysN3,6862,194 / 2,19799%98%

Report on Additional MDUFA II Performance Commitments

 

MDUFA II holds FDA to several commitments related to the medical device review process in addition to performance goals. These commitments include maintenance of performance in areas not covered by explicit performance goals, implementation of an interactive review program, and use of formal and informal meetings to advance reviews. Other performance commitments include quarterly reports on performance, continued focus on reviewer training, and development of guidance documents. Additional information on these commitments is presented in section I, paragraphs G through P, of FDA’s Commitment Letter in Appendix A.

 

Measuring Performance. MDUFA II commitments are presented using quantitative measures (standard statistics) and descriptive measures, where applicable, to assess performance. For descriptive measures, progress is reported through narrative accounts outlining specific actions taken, in addition to any results attributed to those actions. For example, FDA’s implementation of an interactive review program can be described, but not quantified.

 

Maintenance of Current Performance

 

The tables below present FDA’s review performance for submissions over the last 5 years that do not have specific MDUFA II performance goals. Two separate tables are provided for greater insights into CDRH’s and CBER’s performance. With the exception of HDEs, CDRH’s performance in FY 2008 continued to be comparable to performance from the previous 4 years.

 

CDRH Performance Indicators*FY 04FY 05FY 06FY 07FY 08
IDEs - Percent of decisions made within 30 days100%96%99%99%99%
IDE Amendments - Percent of decisions made within 30 days100%98%100%98%98%
IDE Supplements - Percent of decisions made within 30 days100%100%100%99%100%

* Under MDUFA II, FDA no longer reports on cycle goals. Therefore, FDA will no longer report on the CDRH performance indicator, “HDEs – Filing to first action (average FDA days).”

† Only two HDEs were approved during FY 2008 and one was a first-of-a-kind submission with major scientific challenges. This problematic submission was not typical and because only one other HDE was approved, the review time statistic was skewed.

KEY:      HDEs-Humanitarian Device Exemptions; IDEs-Investigational Device Exemptions
NOTE: Some reported measures may change over time, as additional actions are taken on open applications.

With the exception of PMA supplements (percent of decisions within 135 days), CBER’s performance in FY 2008 continued to be comparable to performance from the previous 4 years.

 

CBER Performance IndicatorsFY 04FY 05FY 06FY 07FY 08
BLA Supplements (CBE/CBE-30) -  Percent reviewed and acted on within 6 months100%100%100%100%100%
PMA Supplements (CBE) - Percent of decisions made within 180 days100%100%100%100%100%
PMA Supplements (135 day) - Percent of decisions made within 135 days100%100%100%100%80%
PMA Supplements (CBE-30) - Percent of decisions made within 30 days100%100%100%100%100%
KEY:      BLA-Biologic License Application; PMA-Premarket Approval Application; CBE-Changes Being Effected
NOTE: Some reported measures may change over time, as additional actions are taken on open applications.

 

Interactive Review

In December 2007, FDA implemented an interactive review process, meeting the time frame set forth in MDUFA II. FDA is now applying interactive review as the standard process to provide for, and encourage, informal communication between FDA and sponsors, and to facilitate timely completion of device reviews based on accurate and complete information. FDA issued a final guidance on the interactive review process in December 2007, and issued a revised edition in February 2008. The current edition of this guidance is available at: http://www.fda.gov/cdrh/ode/guidance/1655.pdf.


Biologics Applications Review Performance for FY 2008

Although MDUFA II does not provide specific performance goals for biologics applications, FDA will continue to report on performance for biologics applications starting with FY 2008. This approach is part of FDA’s general commitment to maintain performance on review workloads not covered by specific performance goals. For future reporting of biologics applications, FDA will update the previous fiscal year’s performance and present the performance for the current fiscal year’s reporting period.

 

The tables below present FDA’s performance in reviewing and acting on biologics applications received in FY 2008. The performance targets used to prepare these measures are those that were in effect in FY 2007, the final year of MDUFMA I performance goals. As of September 30, 2008, FDA exceeded the review performance goal for “Class 1” BLA and BLA efficacy supplement resubmissions and is assured of exceeding the MDUFA performance goal for BLA manufacturing supplements for FY 2008. With submissions still pending action and not overdue for standard original BLAs and “Class 2” BLAs and BLA efficacy supplement resubmissions, it is too early to make these final performance determinations for FY 2008.

 

Goals

Review Within

Target

Fiscal YearCohort ClosedReceived

Number on

Time / Actions Completed

Percent on TimePerformance Target
BLAs

Review and act on

priority original BLAs

6 months2008Y00 / 0n/a90%
Review and act on standard original BLAs10 months2008N140 / 0n/a90%
BLA SUPPLEMENTS
Review and act on BLA manufacturing supplements that require prior approval4 months2008N222204 / 204100%90%
Review and act on priority BLA efficacy supplements6 months2008Y00 / 0n/a90%
Review and act on standard BLA efficacy supplements10 months2008Y00 / 0n/a90%
RESUBMITTED BLAs AND BLA EFFICACY SUPPLEMENTS
Review and act on “Class 1” original BLA and BLA efficacy supplement resubmissions2 months2008Y102100 / 10298%90%
Review and act on “Class 2” original BLA and BLA efficacy supplement resubmissions6 months2008N21 / 1100%90%

Meetings

FDA continues to encourage meetings with regulated industry as an effective way to ensure that both FDA and applicants understand the clinical, scientific, and regulatory issues associated with new technologies. Pre-IDE and pre-PMA meetings have shown to be beneficial and are used routinely by industry. More formal types of meetings (agreement, determination, and 100-day meetings) are also available, but are not used as frequently by premarket applicants.

 

Quarterly Performance Reports

FDA reported its quarterly progress toward meeting the quantitative MDUFA II goals. The latest quarterly performance report is typically posted in the month following the close of each quarter and is available at: http://www.fda.gov/cdrh/mdufma.

 

Reviewer Training

FDA continued to invest in internal and external training opportunities supporting the medical device review process. CDRH’s Staff College is a premier workforce development organization that designs and delivers internal training opportunities to meet the professional needs of FDA staff. The Staff College categorizes internal training into the following categories: Regulatory and Law, Science, Leadership Education and Development, and Professional Development. These categories represent the core business and science competencies identified for staff and intended to result in desired behaviors, skills, knowledge, and abilities employees need to do their jobs successfully. FDA periodically prepares a summary of Staff College training; the latest report is available at: http://www.fda.gov/cdrh/mdufma.

 

Guidance Document Development

FDA continued to consider guidance documents for development and provided stakeholders an opportunity to provide comments and/or draft language for those topics as well as suggestions for new or different guidances. The current list of topics under consideration for guidance is available at: http://www.fda.gov/cdrh/mdufma/guidance/agenda/fy09.html.

 

Imaging Devices with Contrast Agents or Radiopharmaceuticals

During FY 2008, FDA published a draft guidance, “Guidance for Industry: New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products,” as called for by the FDA Commitment Letter. The draft guidance is available at: http://www.fda.gov/oc/combination/contrastimg.pdf.

 

In Vitro Diagnostics

Under the FDA Commitment Letter, FDA is studying and pursuing a variety of approaches to clarify its regulatory requirements and reduce regulatory burdens. As part of this effort, FDA has published two new guidance documents specifically called for in the FDA Commitment Letter:


 


 

Appendix A: September 27, 2007, Commitment Letter from HHS Secretary to Congress

 

THE SECRETARY OF HEALTH AND HUMAN SERVICES

Washington, DC, September 27, 2007

 

Edward M. Kennedy

Chairman

Committee on Health, Education, Labor, and Pensions

United States Senate

Washington, DC 20510

 

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

Enclosures

cc: Senator Enzi


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% of non-expedited filed submissions within 180 days, and for 90% within 295 days.

B. Expedited Original PMA and Panel-Track PMA Supplement Submissions

FDA will issue a decision for 50% of expedited filed submissions within 180 days, and for 90% within 280 days.

C. PMA Modules

FDA will take action on 75% of PMA modules within 90 days, and on 90% within 120 days.

D. 180-Day PMA Supplements

FDA will issue a decision for 85% of 180-day PMA supplements within 180 days, and for 95% within 210 days.

E. Real-Time PMA Supplements

FDA will issue a decision for 80% of real-time PMA supplements within 60 days, and for 90% within 90 days.

F. 510(K) Submissions

FDA will issue a decision for 90% of 510(k)s within 90 days, and for 98% 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 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 the 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 lit 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% 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.

 


Footnotes

[1] See the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-250 (October 26, 2002).

[2] Title II of the Food and Drug Administration Amendments Act of 2007, P.L. 110-85 (September 27, 2007).

[3] The new goals are outlined in a September 27, 2007, letter from HHS Secretary Michael O. Leavitt to Congress. For convenience, this report refers to this letter as FDA Commitment Letter. The complete text of the letter is provided in Appendix A and is available at: http://www.fda.gov/cdrh/mdufma/commitmentletter.pdf.

[4] A cohort remains open, or active, as long as there are applications for which FDA has not yet made a decision. Until FDA makes a decision on each application within a cohort, FDA must update its reported performance each year to reflect decisions made within the past year.

[5] See Premarket Approval Application Modular Review – Guidance for Industry and FDA Staff for more information, available at: http://fda.gov/cdrh/mdufma/guidance/835.pdf.

[6] The MDUFA Cohort for 510(k)s excludes submissions that were closed for any reason other than an SE or NSE decision (for example, when FDA finds that a 510(k) was not required). Each MDUFA cohort count is subject to change until that cohort is closed.