Alliance of Specialty Medicine Comments on IOM Report

The Institute of Medicine (IOM) released their long-awaited report "Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years" on July 29, 2011. The report, commissioned by the Food and Drug Administration (FDA) in 2009, evaluates the FDA's 510(k) clearance process and recommends replacing the 510(k) clearance process. Learn more »

On September 30, the Heart Rhythm Society, as a member of the Alliance of Specialty Medicine, submitted a  letter on the IOM Report to FDA Commissioner, Margaret A. Hamburg, MD. The Alliance supports the FDA's position not to eliminate the 510(k) program.

Highlights of the Report:

The Alliance agrees with the IOM's recommendations urging the FDA to evaluate post-market surveillance to improve data collection on the potential harm or lack of effectiveness of marketed devices. Signals of product concerns captured in clinical registries and electronic health records may be detected and reported to the FDA through the Sentinel Initiative to initiate an investigation. The Sentinel Network must include more specialist clinical data repositories, such as HeartNet, a sentinel network for electrophysiology laboratories. The Alliance urges Congress to provide FDA with additional resources to direct FDA's Sentinel Initiative to integrate reporting through registries and electronic health records.

The Alliance calls on Congress to provide additional resources to the FDA to enable it to improve the timeliness of the development, adoption, and implementation of guidance, standards, and regulations and to increase accountable to achieve these goals.

The Alliance urges Congress to also provide additional resources to FDA to enhance efforts to recruit, retain and train personnel and increase their professional development experiences.

Read the full letter (PDF, 123K)