Prof. Hall Presents Study on 510(k) to the IOM

Professor Ralph Hall presented findings of his study "Using Recall Data to Assess the 510(k) Process," funded by the Kaufman Foundation to an Institute of Medicine meeting. The public workshop was the third of the IOM's Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, which provides feedback to the FDA on the effectiveness of its process in ensuring safety among products made available to the public. Subsequent to the workshop, the FDA announced assessments and potential changes to the system.

To see the FDA report, click here: FDA 510(k) Report."