A Medical Device Daily

The Office of Device Evaluation (ODE) at FDA's Center for Devices and Radiological Health published its report for 2006 and 2007, and one of the take-aways is that while the agency took in about 9% more applications and submissions related to devices, the number of PMAs and 510(k)s making it through the agency pipeline is flat, at best.

The numbers come at a time when investment in device development has grown steadily, but FDA funding has generally not kept pace with its mission despite user fees. Device makers have complained that they get little value for their user-fee dollar, but the agency faces a now-legendary set of distractions, and may get yet another new commissioner in January.

According to FDA's count, ODE took in 9,276 "major submissions" in fiscal 2007, a category that includes PMAs and PMA supplements and applications for investigational device exemptions and related supplements. Other filings included in that total are 510(k)s, requests for device reclassification, and humanitarian device exemptions and related supplements (the numbers for 2004 and later do not include applications made to the Office of In Vitro Diagnostics).

The number of major submissions was down from 9,415 the previous fiscal year, but in fiscal years 2004 and 2005, ODE examined roughly 8,500 and 8,700, respectively, so the load at ODE has risen, as the rising level of investment in devices over the past few years suggested it would.

One of the more interesting trends in the numbers at ODE is the lack of a trend regarding PMAs, which jump around quite a bit. Starting in 2004, the annual figures for PMA filings are 37, 43, 25 and 31. In marked contrast, the number of PMAs granted has held steady over that same period, starting in 2004 at 29 approvals, then dropping by one each of the following years. In 2007, FDA granted another 27 PMAs, but also rejected seven and wrote approvable letters for another seven (applications that carry over from one year to the next can create mismatches).

PMA supplement filings were all over the map, numbering 565 in 2004 and rising to 712 in '05 and more than 1,100 the following year. That total tapered off slightly to 1,087 in 2007.

Over that four-year stretch, applications for investigational device exemptions (IDEs), trended fairly stably, starting out at 222 in 2004 and ending up at 211 three years later. The highest year of the four, 2006, included 251 IDEs.

FDA's performance numbers during this time were mixed, but while the final numbers are not in for 2007, the duration of time for all types of applications seems to be trending down, even if only slightly.

The average total agency review time for PMAs and PMA panel-track supplements fell to 283 days in 2006 from a six-year high of 366 the previous year. However, that average review time of 283 days was identical to the same measure in 2001. The best year, 2003, yielded an average time of 229 days.

Thanks to the effect of clock-stopping activities between the agency and device makers, the average total review time runs higher than the agency review time, although the trends generally run parallel. In fiscal 2005, average total elapsed time ran to 438 days and dropped sharply to 335 days the following year. Prior to 2005, the year with the lengthiest average elapsed time was fiscal 2002, at 425 days.

The average elapsed FDA days for 180-day PMAs gradually tracked down between 2001 and 2007, from 119 to 95, with a slight up-tick in fiscal 2005, to 111 days from 107 in 2004. The average elapsed total days exhibited a similar curve, although the spike upward between 2004 and 2005 was much sharper, jumping from 181 total elapsed days to 238. Still, elapsed total days for 180-day PMAs fell to 126 for fiscal 2007.

The interest in third-party reviews of 510(k)s seems to have peaked, but may be renewed thanks to congressional action. According to FDA's numbers, ODE received 233 such applications in fiscal 2007, "a 16% decrease from the 278 submissions received in 2006." Only 21 device companies took this route in 2001, and the numbers tracked reliably upward until the drop last year.

The sputter between 2006 and 2007 may have stemmed from the fact that the third-party program would have expired last year but for the FDA Amendments Act of 2007, which kept the program in play for another five years.

One of the more remarkable statistics provided in the report is that average FDA review times for investigational device exemptions have tracked with little deviation, numbering 28 in 2001 and never going up or down more than one in any subsequent year.

FDA eyes India for office

As foreign economies grow, their impacts on FDA's operations do as well. Hence the agency's interest in setting up office in China is not an isolated case.

According to wire reports last week, FDA deputy commissioner Murray Lumpkin pegged India as the next priority for overseas offices. "Our hope is we would be able at least to begin having a presence in India toward the end of this calendar year, or at the very beginning ... of 2009," Lumpkin is quoted as saying.

New Delhi and Mumbai are the most likely locations for a presence in the world's second-most-populous nation, which has drawn interest both for production of medical products and for being a popular site for clinical trials.

"A lot of this is driven by where the industry decides to go to do its business to bring products into the U.S.," Lumpkin said.

The agency also is interested in opening an office in Amman, Jordan, and in Central or South America. Lumpkin characterized these offices as being "as much a part of the way the FDA has to do its business as having an office in San Francisco or having an office in Philadelphia."