CDRH senior staff will meet in late August to iron out fiscal year 2006 priorities now that they have a clearer picture of expected user fee revenues.

FDA device center officials are relieved that the user fee program will continue, following President Bush's signing of the "Medical Device User Fee Stabilization Act of 2005" Aug. 1, Assistant Director for Strategic Planning Robert Navazio told The Gray Sheet.

However, CDRH is now assessing how it will move forward with potentially lower revenues than it had hoped for.

"We are trying to understand what the impact of the new legislation is fiscally and trying to make plans for next year and beyond," Navazio said.

The new law, which prevented the device user fee program from expiring on Sept. 30 by forgiving appropriations shortfalls from FYs 2003 and 2004, includes a provision that limits annual user fee hikes to 8.5%.

CDRH wanted more flexibility to raise fees to help it meet its premarket review deadlines (¹ Also see "AdvaMed 2005 Annual Meeting In Brief" - Medtech Insight, 14 March, 2005., p. 27).

In addition, the new law redefines small businesses, which receive user fee discounts, as those with annual sales of up to $100 mil. Previously, the small business threshold was $30 mil. (² Also see "Small Biz Threshold Stretched As “Trigger-Fix” Bill Clears Senate Committee" - Medtech Insight, 25 July, 2005., p. 10).

At an Aug. 23-24 retreat, CDRH staff will consider initiatives that can be pursued in light of the need to meet increasingly demanding user fee review time targets under the Medical Device User Fee & Modernization Act. They may also need to consider what efforts need to be slowed or halted because of user fee revenue limitations.

As of the end of the second quarter of 2005, Office of Device Evaluation reviewers were meeting FY 2005 MDUFMA review time targets on original and panel-track supplement PMAs, 180-day PMA supplements, and 510(k)s. They were also meeting FY 2006 goals for expedited PMAs, according to a July 1 ³ presentation to staff by Navazio.

The presentation covered CDRH's Q2 "organizational scorecard" results. The scorecard is a measurement tool established under the center's 2000-2005 strategic plan.

The plan has focused on incorporating a total product lifecycle model for device regulation; improving knowledge management; assessing CDRH's public health impact; and building a workforce to meet future needs (⁴ Also see "MDUFMA Retains Center Stage In FY ’05, With Postmarket In Supporting Role" - Medtech Insight, 1 January, 2005., p. 7).

CDRH leaders hope to continue these initiatives in the coming year, Navazio indicated. A key priority, outside of meeting MDUFMA premarket review goals, will be to generate metrics for postmarket surveillance activities.

By the end of this year, CDRH aims to establish time targets for reviewing death and serious injury adverse event reports and for processing warning letters and recalls. The center is "trying do for ourselves what [MDUFMA] does for us in application review clocks," Navazio said.

CDRH's adverse event reporting and recall procedures have been in the public spotlight following numerous safety alerts on Guidant's cardiac rhythm management products over the past three months (⁵ Also see "Grassley Requests FDA Info On Guidant ICD Alerts Following NEJM Article" - Medtech Insight, 25 July, 2005., p. 5).

The device center's FY 2005 strategic goals include 20 distinct projects, several of which will likely carry over into 2006, suggests a July 29 status report by CDRH Director Dan Schultz.

One of those projects is to approve and send up for FDA clearance a number of new, high priority guidances. Schultz reported that the center is on track to meet its 2005 target of completing 29 of 41 such guidances.

Several other projects relate to developing and incorporating new electronic systems for application review and pre- and postmarket document tracking.

One metric where the center is falling behind targets is in staff hiring, according to Navazio's July presentation. Specifically, CDRH did not meet its goal of hiring 75% of approved hires by the beginning of the third quarter.

Third quarter organizational scorecard results from each CDRH office were due July 29 and will likely take about a month to analyze.

CDRH To Consider Future Priorities In New “Stabilized” User Fee Climate

More from Archive

More from Medtech Insight