Two national medical device organizations are urging Congress to take action this year to insure that the medical device user fee program is not terminated on September 30 due to shortfalls in funding. AdvaMed and MDMA are calling for full-funding of FDA’s Center for Devices and Radiological Health, user fee rate increases that match the rate of inflation, as well as a clarification of labeling requirements for reprocessed single-use medical devices.

MassMEDIC’s FDA Working Group met in early June to consider an appropriate public policy position to pursue, including support for the national organizations’ full-funding and user fee rate increases tied to inflation. A policy statement letter is being drafted and will be posted on MassMEDIC’s website, once authorized.

The Massachusetts Legislative Committee on Public Health has scheduled a hearing for October 19th on a series of healthcare bills, including Sen. Susan Tucker’s (D-Andover) legislation that would require patient consent before certain reprocessed single-use medical devices are used. The legislation has been the cornerstone of MassMEDIC’s Re-use Working Group’s agenda since November. The State Legislature is currently completing work on the FY’06 budget and may consider an economic stimulus bill before taking its summer recess.

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