FDA Releases Guidance on Single-Use Medical Device Labeling Requirements

Summary

The Food and Drug Administration (FDA) has released a guidance document outlining the requirements for manufacturers to display a prominent and conspicuous mark on single-use medical devices. The document is part of the Medical Device User Fee and Modernization Act of 2002, as amended, which was enacted on August 1, 2005, and requires the FDA to issue the guidance within 180 days.