Devices & Diagnostics

Small study: 64% of device makers dissatisfied with 510(k) process

A small study of device makers has found that most companies are dissatisfied with the […]

A small study of device makers has found that most companies are dissatisfied with the U.S. Food and Drug Administration’s 510(k) process.

Out of 128 survey respondents who answered a question about their experiences with the FDA’s 510(k) pathway, 64 percent said they were either “extremely dissatisfied” or “somewhat dissatisfied.” The survey was commissioned by the MedTech Resource Alliance based in Minnetonka, Minnesota.

The groups that report the highest dissatisfaction are ophthalmic, neurological and ENT device companies, while those with the highest satisfaction make cardiovascular devices, infection-control and dental devices as well as devices for anesthesiology and hospitals.

The primary reason for dissatisfaction appears to be a delay in communication, especially if the FDA ultimately ruled that the product could not be cleared because it wasn’t substantially equivalent to a product currently available in the market, the basis by which 510(k)s are granted. Out of 129 participants, 43 percent agreed that the FDA paused its review after doing a quick evaluation without reviewing performance data and issued a “not substantially equivalent” ruling or indicated that it will.

Another source of discontent appears to be what device makers perceive as a lack of scientific expertise at the FDA. Only 7 percent out of 55 participants said that in issuing the NSE ruling, the FDA demonstrated sound scientific issues that the device posed. Nearly 30 percent said the FDA staff was “extremely confused,” while another 27 percent said it was “somewhat confused.”

Read the full report here.

[Photo Credit: Free digital Photos user t0zz]

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