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House Subcommittee Grills Shuren On Facility Inspection Shortfalls

 
• By Sue Darcey

Members of the House Energy & Commerce Health Subcommittee probed FDA device-center chief Jeff Shuren about the agency's nascent efforts to improve facility inspections during a recent hearing on user-fee reauthorization. Lawmakers say they are hearing complaints from constituents about a lack of consistency and transparency in FDA inspection practices. Bills have now been introduced in both the House and Senate to address the issue, while FDA embarks on its "program alignment" upgrade to its inspections program.

Lawmakers pressed FDA Device Center Director Jeff Shuren on FDA's plans to improve the facility inspection process of device firms during a recent hearing.

During a March 28 session on device user-fee reauthorization, House Energy and Commerce Health Subcommittee members generally expressed support for the provisions of a Medical Device User Fee Agreement (MDUFA...

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