The winds of change are still blowing at FDA in 2012. The year has seen not only an extension of efforts to reform and improve FDA but also new policies and regulations that will affect FDA procedure. July 2012 saw President Obama sign the Food and Drug Administration Safety and Innovation Act (FDASIA) into law. FDASIA’s overall goal is to improve FDA and industry partnership. Key provisions include an expedited supervisory review appeal process, allowing FDA to reclassify devices by administrative order rather than regulation, and adjustment to the Sentinel program, which will allow FDA to use commercial and insurance data to monitor devices on the market. Most prominent, however, is FDASIA’s increase in user fees. Under the new act user fees will increase to $609 million in 2013-2017, up from their current level of $277 million from 2008–2012. The aim is to assist FDA with additional funding and help device manufacturers get to market faster.
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Figures 1–3. PMA and 510(k) submissions were at or near five-year highs in 2011. Source: FY 2011 MDUFA Performance Report to Congress. |
Medical device user fees were first authorized in 2002, under the Medical Device User Fee Modernization Act (MDUFMA I) for fiscal years 2003–2007. Now, under the amended MDUFA II, which is in effect through fiscal year (FY) 2012, FDA has committed to more stringent performance goals to improve the timeliness and predictability of medical device reviews. The two-tiered system divides performance goals based on short- and long-term review times (based on times previously established by MDUFMA I). This two-tiered approach is intended to ensure that a significant number of reports are completed in a shorter number of days by providing quantifiable goals.
FDA’s FY 2011 MDUFA Performance Report to Congress states that, based on preliminary data of completed and pending reviews, FDA has the met or has the potential to meet or exceed 17 of 21 Tier 1 performance goals and 15 of 21 Tier 2 goals. However, the report also shows that, despite these goals being met, the total time for review (FDA time combined with industry time) has been increasing. In her commissioner’s report, FDA commissioner Margaret A. Hamburg states that in January 2011 FDA announced a plan of action for improvement. Hamburg states the aim is to “create a culture change toward greater transparency, interaction, collaboration, and the appropriate balancing of benefits and risk; ensure predictable and consistent recommendations, decision-making, and application of the least-burdensome principle; and implement efficient processes and use of resources.”
The FY 2011 MDUFA report shows (Figure 1) that PMA, panel-track PMA supplement, and premarket report MDUFA cohort submissions reached the second-highest level in five years in 2011 (2010 being the five-year high). From FY 2008–2012, for nonexpedited filed submissions, 60% of decisions were issued on time for Tier 1, with this number increasing to 90% for Tier 2 (Figure 2). The number of 510(k) submissions under the MDUFA cohort portion (representing 94 of every 100 submissions) reached a five-year high in 2011 and decisions for 501(k)s were delivered 90% on time for Tier 1 and 98% for Tier 2 (Figure 3).
Overall, FDA has reported consistent year-to-year performance with regard to the expectations set by MDUFA II. However, FY 2012 marks the final year under the current amendment. Based on future performance and overall performance in FY 2008 through FY 2012, it will be interesting to see if FDA makes further revisions to create more lenient performance goals or perhaps to push itself further.
| Goal | Tier | Performance Goals | Fiscal Year | Received | Pending Within Goal |
Overdue | On Time | Percent On Time |
Met Goal |
| Issue a decision for non-expedited Filed submissions |
1 | Issue 60% within 180 days | 2008 | 33 | 0 | 12 | 21 | 64% | Y |
| 1 | Issue 60% within 180 days | 2009 | 41 | 0 | 9 | 32 | 78% | Y | |
| 1 | Issue 60% within 180 days | 2010 | 54 | 7 | 12 | 35 | 74% | Y | |
| 1 | Issue 60% within 180 days | 2011 | 42 | 28 | 3 | 11 | 79% | P | |
| 2 | Issue 90% within 295 days | 2008 | 33 | 0 | 7 | 26 | 79% | N | |
| 2 | Issue 90% within 295 days | 2009 | 41 | 0 | 6 | 35 | 85% | N | |
| 2 | Issue 90% within 295 days | 2010 | 54 | 12 | 2 | 40 | 95% | P | |
| 2 | Issue 90% within 295 days | 2011 | 42 | 30 | 0 | 12 | 100% | P |
Performance indicators for FY 2008 through FY 2011 show that FDA has met, or is capable of meeting, performance goals for decisions issued for non-expedited filed submissions. Source: FY 2011 MDUFA Performance Report to Congress.
| Goals | Tier | Performance Goals | Fiscal Year | Received | Pending Within Goal |
Overdue | On Time | Percent On Time |
Met Goal |
| Issue a decision for 510(k)s | 1 | Issue 90% within 90 days | 2008 | 3310 | 2 | 208 | 3100 | 94% | Y |
| 1 | Issue 90% within 90 days | 2009 | 3444 | 1 | 357 | 3086 | 90% | Y | |
| 1 | Issue 90% within 90 days | 2010 | 3224 | 72 | 303 | 2849 | 90% | P | |
| 1 | Issue 90% within 90 days | 2011 | 3660 | 1697 | 104 | 1859 | 95% | P | |
| 2 | Issue 98% within 150 days | 2008 | 3310 | 2 | 53 | 3255 | 98% | Y | |
| 2 | Issue 98% within 150 days | 2009 | 3444 | 1 | 83 | 3360 | 98% | Y | |
| 2 | Issue 98% within 150 days | 2010 | 3224 | 90 | 56 | 3078 | 98% | P | |
| 2 | Issue 98% within 150 days | 2011 | 3660 | 1740 | 8 | 1912 | 99% | P |
In 2011 510(k) decisions were delivered on time 90% of the time for Tier 1 and 98% of the time for Tier 2. ?Source: FY 2011 MDUFA Performance Report to Congress.
| Performance Indicators | FY 07 | FY 08 | FY 09 | FY 10 | FY 11 |
| BLA Supplements (CBE/CBE-30) – Percent Reviewed and acted on within 6 months |
100% | 100% | 100% | 100% | 100% |
| IDEs – Percent of decisions made within 30 days | 99% | 99% | 99%a | 98% | 100% |
| IDE Amendments – Percent of decisions made Within 30 days |
98% | 98% | 99%a | 99% | 99%a |
| IDE Supplements – Percent of decisions made Within 30 days |
99% | 100% | 99% | 99% | 99% |
| PMA Supplements (CBE) – Percent of decisions Made within 180 days |
100% | 100% | 100% | _b | 100% |
| PMA Supplements (135 day) – Percent of decisions Made within 135 days |
100% | 86% | 100% | 100% | 100% |
| PMA Supplements (CBE - 30) – Percent of decisions Made within 30 days |
100% | 100% | 100% | 100% | 100% |
| Percentages above 99%, but below 100% are Rounded down to 99% |
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| b No PME (CBE) supplements were received in FY 2010 |
A review of FDA performance for submissions that do not have explicit MDUFA II performance goals. Source: FY 2011 MDUFA Performance Report to Congress.
| Goal | Tier | Review Time | Performance Level FY 2008 – FY 2012 Submissions |
| Issue a decision for 180-day PMA supplements | 1 | 180 | 85% on time |
| 2 | 210 | 95% on time |
Shown is a summary of Tier 1 and 2 performance goals for 180-day PMA supplements. Performance goals are appllied to MDUFA cohort submissions. Source: FY 2011 MDUFA Performance Report to Congress.
—Chris Wiltz is the Associate Editor at MD+DI
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