Shuren Promises End to Unilateral Device Clearance Standards

Medical device makers may soon get one of their greatest wishes granted by the U.S. Food and Drug Administration (FDA).

Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH), claims his agency is working to make medical device clearance standards more consistent and predictable. Companies have long complained about inconsistent standards and sudden changes in the approval process when applying for 510(k) clearance or pre-market product approval.

Such inconsistencies and out-of-the-blue process changes, however, are about to end. Shuren said reviewers at the FDA’s Office of Device Evaluation no longer will be able to change the standards for device clearances and/or approvals without a manager’s okay. The revelation came during a plenary breakfast panel during the final day of AdvaMed 2011 – The MedTech Conference inWashington, D.C. The panel featured Shuren and John M.Taylor III, counselor to the FDA Commissioner. Taylor also served as acting principal deputy commissioner from January through July.

Taylor and Shuren spoke about the direction of the FDA and its impact on and relationship with, device makers. Shuren also addressed user fee negotiations, claiming the agency “needs the funding” derived from user fees, but acknowledging that merely more resources will not speed up product review cycles.