New Survey Aims To Convey 510(k) Concerns To Policymakers

Article preview from "The Gray Sheet" - January 10, 2011

Researchers from Northwestern and Stanford universities are planning to survey thousands of device industry reps in hopes of giving the Institute of Medicine a clearer picture of challenges faced within the 510(k) clearance process.

New Survey Aims To Convey 510(k) Concerns To Policymakers

Article preview from "The Gray Sheet" - January 10, 2011

Researchers from Northwestern and Stanford universities are planning to survey thousands of device industry reps in hopes of giving the Institute of Medicine a clearer picture of challenges faced within the 510(k) clearance process.

John Linehan, a professor of biomedical engineering at Northwestern University, and Jan Pietzsch, CEO of Wing Tech and an associate professor at Stanford, are doing a comprehensive analysis of the 510(k) program, under a grant from the Institute for Health Technology Studies (InHealth).

They discussed the study, including the planned survey, during a Dec. 22 conference call.

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