An editorial in the journal said the FDA’s process of using existing devices as the basis for evaluating safety and effectiveness of a new device is “untenable” and should be stopped immediately for Class III devices.
Answering device industry concerns that a more extensive review would be a burden, the journal noted ongoing lawsuits on metal-on-metal hip implants that could cost Depuy Orthopaedics up to $1 billion.
Read the Mass Device report on overhauling the FDA’s medical device approval process.
Related Articles on the FDA Medical Device Approval Process:
FDA Clarifies Device Approval Process
FDA Seeking Comment on IOM Device Recommendations
FDA Proposes Updating Device Reviews, Including for Joints, IOLs
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