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.
![]() |
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. |
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 |
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 |
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% |
|||||
b No PME (CBE) supplements were received in FY 2010 |
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 |