FDA device approval times improve, report says.

Since 2002, the FDA's Office of Device Evaluation (ODE) within the Center for Devices and Radiological Health (CDRH) has become faster at approving new product applications from device manufacturers, according to an annual report recently released by the agency.

In fiscal 2006, the agency; on average, took 335 days to approve devices--which can include everything from complex artificial hearts to simple syringes--compared with 438 days in 2005, according to the ODE report.

Decision times--average total FDA review days from filing to approval (excluding withdrawals)--for all original premarket approval applications (PMA) and PMA supplements was 283 days for fiscal year 2006 (PMA data is not yet available for fiscal 2007 and will be included in next year's report), down substantially from 366 days in fiscal year 2005. However, decision times were at their lowest in recent years at 229 days in 2003. For novel devices, manufacturers must file a PMA with extensive clinical data to show the product is safe and effective. The agency also reported "significant improvement" in the average total elapsed time for 180-day PMA supplements since FY05. For FY07, total time was 126 days, down from 169 days in FY06.

The FDA received 9,276 major submissions in fiscal 2007, including 31 PMAs and 1,087 PMA supplements, and 9,415 submissions in fiscal 2006, including 25 PMAs and 1,113 PMA supplements. There was an increase in PMA application and PMA supplement review flames in fiscal year 2005 related to uncertainty about whether the user-fee program would continue, according to the agency.

Approval of devices under the agency's 510(k) application process increased slightly, requiring 95 days on average in 2006, compared with 87 days in 2005. Overall, however, the number has declined from 105 days in 2001. ODE cleared 2,640 devices under the 510(k) process in 2007 compared with 2,677 devices in fiscal year 2006. The 510(k) process requires companies to show "substantial equivalence" to similar products already on the market and usually is not as time-consuming as the PMA review process.

The Medical Device User Fee Stabilization Act, enacted Aug. 1, 2005, kept the user fee program from sunsetting in 2005, and extended it until 2007. Last year's FDA Amendments Act renewed the program until 2012.

As part of the stabilization legislation, the FDA also set up third-party programs that allow agency-approved independent companies to review applications before the agency makes the final decision.

While the report did not give specific 2007 data, it said 16% fewer third-party reviewed applications were submitted (233 compared with 278 in 2006). The FDA Amendments Act, however, eased some restrictions on the third-party process. Critics of third-party review say the FDA should get more funding to do the reviews itself.

Agency performance since 2002 compared to future performance trends most likely will have to be evaluated differently in years to come, as the 2007 amendments significantly revised the agency's performance goal system.

The CDRH's review times had been required by law to meet "cycle goals," which were interim steps that were measured and evaluated on the way to a final approval decision. Although originally intended to speed the premarket approval process, cycle goals often had the opposite effect, according to the agency and some in industry.

Applications that FDA received before Oct. 1, 2007, still fall under the old user-fee goals. The agency expects review time to continue to speed up going forward without the cumbersome cycle goals to slow down the process.

Some of the notable devices approved by the agency since 2006 include Abiomed's AbioCor implantable replacement heart, Smith & Nephew's Birmingham hip resurfacing system, new drug-eluting stents from Medtronic and Abbott, and Infuse bone graft from Medtronic Sofamor Danek.