US FDA's 'Program Alignment' Inspection Scheme Coming Mid-May; Details Still Murky
The agency's new inspectional approach – which will be structured along commodity-specific product lines – will be ready for primetime on May 15, the device center's compliance chief says.
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'Program Alignment' Falls Into Place: Everything You Need To Know About US FDA's New Inspectional Approach
For the medical device industry, FDA's five regional offices – Pacific, Central, Northeast, Southwest, Southeast – will be replaced by three distinct divisions across the US encompassing 20 FDA district offices on May 15. Check out the latest US map from the agency showing where the device divisions will be located, and find out what your firm will be facing at its next facility inspection.
There has been a dearth of guidances from US FDA since Donald Trump's inauguration, but the acting FDA commissioner says that simply reflects the new administration catching up on what's in the pipeline. In a speech at FDLI's annual meeting, Stephen Ostroff struck a positive tone.
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.