It was a somewhat muted launch today of the agency's long-awaited "program alignment" facility 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.

The agency says it has sent letters to dozens of companies that have made ‘FDA Registration Certificate’ claims or used the agency’s logo without authorization, which could lead customers to think the products have been vetted.