Minnesota Devicemakers Meet With Hamburg, Push 510(k), Other Reforms

Reforms in the FDA’s 510(k) procedures are needed to encourage risk-taking and speed the pace at which “substantially equivalent” devices are cleared for marketing, an industry expert says. “Everything at FDA is becoming a science project, and reviewers cannot see the forest because they are staring at one tree,” attorney Mark DuVal, president of DuVal & Associates, said.
Devices & Diagnostics Letter