Management Challenges for FY 2011
Medical Device Review Performance Goals for FY 2008 through FY 2012
Type of Goal
Review Time Goal
Premarket approval application (PMA), panel-track PMA supplement, premarket report
Expedited PMA, expedited panel-track PMA supplement
180-day PMA supplement
Real-time PMA supplement
510(k) premarket notification
Substantially Equivalent (SE) or Not Substantially Equivalent (NSE) Decision
An “FDA Action” on a PMA module is any of the following: accepting the module, a request for additional information, receipt of the PMA, or withdrawal of the module.
- The FY 2008 – FY 2012 goals do not vary from one fiscal year to the next. Instead, each goal will apply throughout the five years from FY 2008 through FY 2012.
- Except for PMA modules, all of FDA’s performance goals focus on making an “FDA decision” and FDA will not have any cycle goals. PMA decisions are approval, approvable, approvable pending Good Manufacturing Practices (GMP) inspection, not approvable, withdrawal, and denial. 510(k) decisions are substantially equivalent (SE) or not substantially equivalent (NSE).
- For PMA modules only, FDA’s performance goals focus on FDA taking an “action” on the module. An “FDA action” on a PMA module is any of the following: accepting the module, a request for additional information, receipt of the PMA, or withdrawal of the module. PMA modules are not subject to a decision goal, because the modular submission is converted to a PMA upon submission of the final module.
- Each goal has two tiers, and all submissions are measured in both tiers. Compared with the lower tier, the upper tier of each goal provides for additional review time, but requires a higher percentage of reviews to have an FDA decision (or, in the case of PMA modules, an FDA action) within the specified review time. The use of two tiers helps ensure that FDA focuses on all applications within a cohort, rather than just those that are most likely to reach an FDA decision quickly.