Management Challenges for FY 2010
On September 27, 2007, the President signed the Food and Drug Administration Amendments Act of 2007 (FDAAA). 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 calls 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 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),
|FDA Decision||180 days|
|Expedited PMA, expedited panel-track PMA supplement||FDA Decision||180 days|
|PMA module||FDA Action||90 days|
|180-day PMA supplement||FDA Decision||180 days|
|Real-time PMA supplement||FDA Decision||60 days|
|510(k) premarket notification||Substantially Equivalent (SE) |
or Not Substantially Equivalent
An "FDA Decision" is any of the following: a denial order, an approvable letter (including approvable pending GMP inspection), a not 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 SE or 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.
Pursuant to section 738(c)(2) of the Federal Food, Drug, and Cosmetic (FD&C) Act, during FY 2010, FDA must determine whether it must increase the establishment registration fee for fiscal years 2011 through 2012 to offset any deficit from the registration of fewer establishments than required during FY 2010. If fewer than 12,250 establishments register during FY 2010, FDA may increase the annual establishment registration fee for fiscal years 2011 through 2012 by no more than an additional 8.5 percent. FY 2009 registrations met the threshold requirement, and preliminary data indicates FY 2010 registrations will also meet the threshold, although it is too soon to make a final determination.
FDA is also working hard to implement key provisions of FDAAA by developing and promulgating regulations. FDA is developing —
- A proposed rule amending 21 Code of Federal Regulations (CFR) Part 807 to require medical device establishments to register and list by electronic means, during the period 10/1 through 12/31 each year, and
- A rule amending 21 CFR Part 814 to implement section 515A of the FD&C Act, concerning pediatric uses of devices.
In addition, FDA is gathering data and comments to help develop a rule providing for a unique device identification system, as required by section 519(f) of the FD&C Act.
These actions will strengthen FDA’s ability to meet its regulatory responsibilities and public health missions.