Medical Device Manufacturers Wary of Pharmas
Medical device makers are watching Congress closely as it prepares to review the Medical Device User Fee and Modernization Act (MDUFMA). The act expires at the end of the year.
The Food and Drug Administration has a user-fee program which supports its ongoing review of new products. The review process is linked to the Act; without Congressional reauthorization, the FDA would be unable to review and, thus, approve, new devices.
The medical device community is concerned in light of controversies surrounding the pharmaceutical industry. Some speculate that passage of the drug counterpart for the FDA user fee (PDUFA, the Prescription Drug User Fee Act) will be tied to legislation to improve drug safety and monitoring. Device makers simply don’t want to get caught in the crossfire. See coverage from The Hill.
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- FDA Commissioner Addresses Financial Conflict of Interest
- Efficacy of Device Monitoring Under Fire
- Medical Reprocessing Gains Momentum, Stirs Controversy
March 27, 2007 Related topics: Legal & legislative, Policies & Procedures