Last year around this time, MD+DI said that “the regulatory climate in the United States is changing dramatically.” While we stand by the statement, nothing scary has happened just yet. Actually, what some might consider to be scary are the muddy regulatory waters that ReGen Biologics found itself in with its Menaflex device. Its initial clearance through the 510(k) program was met with resistance from CDRH scientists but ultimately supported by center management. Fast-forward to nearly two years later, and FDA has decided that the knee scaffold device is not ready for the market. This situation is merely the latest in a string of incidents that don’t cast the 510(k) program in a favorable light. But the agency is well aware of its regulatory snafus.

In fact, FDA has been conducting a careful and deliberate evaluation of the beleaguered 510(k) program. Part of that evaluation is an Institute of Medicine study that is still under way and expected to be released in 2011. Another part has been a series of CDRH town hall meetings across the country with concerned stakeholders, led by CDRH director Jeffrey Shuren.

“Our intent is to strengthen the program,” Shuren said in October at a town hall meeting in Irvine, CA. “The intent is not to dramatically raise the bar for device approvals.”

Shuren insisted that any changes to the 510(k) pathway should help the system become more predictable, consistent, and transparent. Transparency has been a buzzword around the agency recently.

“To improve FDA transparency, we are providing educational materials and conducting quarterly performance meetings,” says FDA commissioner Margaret Hamburg in the FY 2009 Performance Report to Congress. “These efforts are expected to improve the quality of submissions, provide more timely reviews, and increase availability to patients and healthcare providers of important new medical devices.”

The report also reveals that FDA

• Met or exceeded two-thirds of the decision performance goals for FY 2004–2007 cohorts under MDUFMA I.
• Has the potential to meet or exceed more than half of the tier 1 performance goals and two-thirds of the tier 2 performance goals for the FY 2008 and FY 2009 MDUFA II cohorts.
• Issued 12 guidance documents to explain and implement key aspects of the MDUFA II program.
• Applied an interactive review program, consulted with its stakeholders, and focused on reviewer training.
• Held quarterly meetings with stakeholders to provide updates on FDA’s performance under MDUFMA I and MDUFA II.

Read on for more specifics of FDA’s performance as well as what industry submitted to the agency for evaluation.

FY 2009 PMA submissions. Source: FY 2009 MDUFA Performance Report to Congress.

Number of medical device listings by medical specialty, with percentages of total listings. Percentages are rounded to the nearest whole number. Source: CDRH database.

FDA’s performance metrics for 510(k) submissions in FY 2008 and FY 2009. The agency has the potential to exceed both the tier 1 and tier 2 performance goals for FY 2009. Source: FY 2009 Performance Report to Congress.

FDA’s performance metrics for PMA submissions in FY 2008 and FY 2009. The agency has the potential to exceed both the tier 1 and tier 2 performance goals for FY 2009. Source: FY 2009 Performance Report to Congress.

The number of 510(k) submissions, along with the MDUFA cohorts, for FY 2009. Source: FY 2009 MDUFA Performance Report to Congress.

Expedited PMAs and panel-track PMA supplement submissions compared with 180-day PMA supplement submissions for FY 2009. Source: FY 2009 MDUFA Performance Report to Congress

FDA’s performance with respect to investigational device exemptions (IDEs) is on par with its performance during the previous four years. Source: FY 2009 MDUFA Performance Report to Congress.