Survey: Change 510(k) process, don't abandon it

Despite a recent Institute of Medicine (IOM) report calling for the FDA to abandon its 510(k) medical device clearance process, many experts think reform, not abandonment, is the best path. That was among the findings in a Northwestern University survey funded by the Institute of Health Technology Studies (InHealth) that drew responses from more than 350 companies engaged in developing medical devices.

Some 76 percent of respondents said they chose to bring a specific product to market outside of the U.S. first. Of those, 22 percent said the cost of conducting clinical trials in the U.S. was too high and another 14 percent claimed regulatory processes were easier outside of the country. Nearly all outside-first respondents cited the unpredictability of the 510(k) requirements.

“In spite of the IOM recommendation that FDA should abandon the 510(k) process, the results of this survey show that there is wide agreement among many experts on 510(k) issues about basic changes that could make this process work better and help America retain its position as the global leader in new medical technologies,” said Martyn Howgill, executive director of InHealth, in a statement. “The real question is exactly what FDA can and will do with this feedback.”

The Northwestern University results conflicted with an IOM study finding that the 510(k) process was “economical, faster and less burdensome to industry than the premarket approval application.” Instead, respondents found that increased testing requirements made the average time from submission to approval equal in both processes—and, as a result, some companies chose to first bring their product to market outside the U.S.

Meanwhile, respondents agreed with an IOM finding that the FDA did not have enough staff to manage 510(k) applications in a timely manner, and said the inconsistencies could be related to staff turnover and varying levels of expertise.

The survey also found:

• A better understanding of “intended use” and “indications for use” would improve efficiency for both companies and the FDA.
• The FDA determination for pre-clinical and clinical data is inconsistent, and guidance documents issued by the FDA are insufficient or oftentimes nonexistent for many device types.
• As noted by the IOM, the de novo process is underutilized due to a number of factors, including lack of clarity, undefined timelines and a perception that FDA staff members discourage those applications.
• Lack of predictability in the 510(k) process is viewed as a barrier to venture capital investment in companies seeking approvals, and may be leading companies to opt for non-U.S. avenues to bring their products to market.

The survey, led by Northwestern bioengineering professor John H. Linehan, PhD, was submitted in late September to the FDA with additional comments on the IOM 510(k) report. The full submission can be found here.