The guidance is meant to improve predictability, consistency and transparency of the premarket approval process so that device manufacturers can navigate the process more easily.
Basically, the process involves consulting safety data –– addressing risk and the manufacturer’s ability to mitigate that risk –– and effectiveness data –– considering benefits and other information –– to determine whether probable benefits outweigh probable risks.
Read the FDA release on its benefit-risk determinations for devices.
Read the full FDA draft guidance.
Related Articles on the FDA Device Approval Process:
FDA Proposes Updating Device Reviews, Including for Joints, IOLs
FDA Seeking Comment on IOM Device Recommendations
FDA Officials Downplay Impact of Upcoming Medical Device Study
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