FDA deputy talks to House about MDUFMA and other legislation
Device Regulation Alert: Safety, Compliance and Reimbursement News, July 9, 2007
FDA Deputy Commissioner Randall Lutter, Ph.D. addressed a House of Representatives Subcommittee about the importance of reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA). The statement was made during a June legislative hearing concerning the MDUFMA, the Prescription Drug User Fee Act Reauthorization and draft pediatric drug and device legislation.
Recommending a "more robust" MDUFMA program, Lutter noted the FDA's concerns about third-party accredited person inspection program. He also expressed disappointment that some FDA-recommended modifications weren't included in the draft reauthorization legislation and suggested Congress add the suggested adjustments
Lutter also discussed the proposed Pediatric Medical Device Safety and Improvement Act of 2007. He said the draft legislation requires the FDA to:
While pointing to the administrative burden associated with the proposal, Lutter questioned the supposed health benefit of the measures.
To read Lutter's full statement, click here.
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