Management Challenges for FY 2012
On September 27, 2007, the President signed the Food and Drug Administration Amendments Act (FDAAA) of 2007. Title II of FDAAA, the Medical Device User Fee Amendments of 2007, reauthorizes medical device user fees for FY 2008 through FY 2012 (MDUFMA II). MDUFMA II called for a new set of challenging performance goals and a new fee structure.
FDA will continue to monitor performance against the goals for the MDUFMA I cohorts that remain open (FY 2004 through FY 2007; the FY 2003 cohort is now closed) and against the new performance goals of MDUFMA II.
The performance goals for applications filed or accepted from FY 2008 through FY 2012 are defined in a September 27, 2007, letter from former HHS Secretary Michael O. Leavitt to Congress; see the following table for a summary of these goals.
Medical Device Review Performance Goals for FY 2008 through FY 2012 Application Type Type of Goal Review Time Goal Performance Goal Premarket approval application (PMA), panel-track PMA supplement, premarket report FDA Decision 180 days 60% 295 days 90% Expedited PMA, expedited panel-track PMA supplement FDA Decision 180 days 50% 280 days 90% PMA module FDA Action 90 days 75% 120 days 90% 180-day PMA supplement FDA Decision 180 days 85% 210 days 95% Real-time PMA supplement FDA Decision 60 days 80% 90 days 90% 10(k) premarket notification Substantially Equivalent (SE) or Not Substantially Equivalent (NSE) Decision 90 days 90% 150 days 98%
An "FDA Decision" is any of the following: an approvable letter (including approvable pending GMP inspection), a non-approvable letter, a withdrawal, or a denial order.
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.
These goals are structured in ways that differ from the goals for FY 2003 through FY 2007:
· 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.
In recent years, CDRH experienced significant growth in the number and the complexity of medical device applications due to an acceleration of scientific discovery. These trends offer not only the promise of exciting new diagnostic tools and devices to improve patient care but also pose significant public health challenges. Americans rely on an assurance from FDA that medical devices marketed for public use will be safe and effective. This assurance must be backed by rigorous and independent scientific analyses and matched with an FDA capacity to keep pace with rapid growth in application volume and complexity.
Through our assessments and extensive public input we have identified several problems with our pre-market programs, their root causes, and solutions. We have embarked on an effort to make the necessary improvements to assure that our pre-market programs are predictable, consistent, transparent, and efficient. Specifically, we are in the process of: (i) creating a culture change toward greater transparency, interaction, collaboration, and the appropriate balancing of benefits and risks; (ii) assuring predictable and consistent recommendations, decision making, and application of the least burdensome principle; and (iii) implementing efficient processes and use of resources.
An example of this is the Innovation Pathway, launched in the Spring of 2011. This program involves FDA earlier in the device development process to help identify issues early on that typically result in delays during regulatory review and to help shepherd qualifying devices through the regulatory process.
We remain committed to improving our pre-market programs, assuring that patients have timely access to safe and effective devices, including cutting-edge technologies.
 See CDRH, “Plan of Action for Implementation of 510(k) and Science Recommendations” (Jan. 2011); CDRH, “Medical Device Pre-Market Programs: An Overview of FDA Actions” (Oct. 19, 2011); and CDRH, “Accomplishments: CDRH Plan of Action for 510(k) and Science -- Implementation” (Oct. 2011); all available at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm239448.htm.