This section updates FDA’s review performance information for FY 2008 and presents FY 2009 review performance for MDUFA II performance goals completed as of September 30, 2009.
MDUFA II increases the focus on making a timely FDA decision, as defined for each type of application. Under this approach, each performance goal consists of two tiers, each with a distinct review time (number of days) and performance level (percentage of submissions on time). Tier 1 performance goals focus on completing a specified proportion of reviews within shorter time frames as compared to performance goals that existed under MDUFMA I. Tier 2 performance goals focus on completing a larger proportion of reviews within somewhat longer time frames that were established under MDUFA II.
Use of the two-tier approach is intended to ensure that a substantial proportion of reviews are completed in a shorter number of days (Tier 1 performance goals). The table below presents an example of this approach using the Tier 1 and Tier 2 performance goals for original PMAs, panel-track PMA supplements, and premarket reports as seen later in this report.
|Goal||Tier||Review Time||Performance Level|
FY 2008 – FY 2012 Submissions
|Issue a decision for non-expedited|
|1||180 days||60% on time|
|2||295 days||90% on time|
MDUFA Tier 1 and Tier 2 performance goals are quantifiable; that is, progress can be measured and described through standard statistics. When determining FDA performance, calculated percentages are rounded to the nearest whole number up to 99 percent. Percentages above 99 percent, but below 100 percent, are rounded down to 99 percent.
When a cohort has submissions pending, there are usually more Tier 2 reviews pending than Tier 1 reviews. When this occurs, preliminary performance information presented for Tier 1 can be considered to be a better predictor of final outcomes than preliminary information presented on Tier 2.
The following information refers to FDA performance presented in this section.
- Review performance statistics are based on a fiscal year receipt cohort. Until all submissions in a cohort receive a final decision or are pending past the goal date, whichever comes first, a preliminary performance assessment is provided for that cohort.
- The MDUFA cohort for each submission type is subject to change until that cohort is closed. A cohort is closed when FDA makes decisions on all submissions. Performance tables indicate if the fiscal year cohort is closed with a “Y” for yes and an “N” for no.
- FDA decisions for PMA submissions are approval, approvable, approvable pending current good manufacturing practice inspection, not approvable, acceptance of withdrawal, or denial of filing. FDA decisions for 510(k) submissions are SE or NSE.
- Submissions that were closed without an FDA decision, as defined in the bullet above, are not included in the statistics used to measure performance. However, the total number of submissions received and the number of MDUFA cohort submissions are noted in the workload tables.
- All references to 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.
- Review-time goals are defined as the time period identified in number of days for when individual submissions are to be acted on. An on-time review indicates that action was completed within the number of days specified by the review-time goal.
- Percent on time refers to the percent of reviews where FDA met a review-time goal for a given type of submission. FDA’s percent on time for a given type of submission is used as a measure of FDA’s performance, and is used to determine whether FDA met or exceeded the MDUFA II Tier 1 and Tier 2 performance goals.
- Performance is based on the number of submissions reviewed “on time” (acted on within goal) and “overdue” (acted on past goal or pending past the goal date) and presented as “percent on time.”