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.
To read the original article: Small study: 64% of device makers dissatisfied with 510(k) process | MedCity News
