OIVD Archived News

FDA Law Allows for Electronic Labeling if Users May Still Request Labeling in Paper Form
(March 9, 2004)

Labeling – The Electronic Labeling Option

In 2002, the Federal Food, Drug, and Cosmetic Act (the Act) was amended by the Medical Device User Fee and Modernization Act (MDUFMA). Among other provisions, section 206 of MDUFMA amended section 502(f) of the Act to provide that labeling for prescription devices intended for use in health care facilities may be provided solely by electronic means, so long as users may request the labeling in paper form and such labeling is promptly provided to requestors without additional cost. Manufacturers electing to provide electronic labeling must ensure that it is not false or misleading in any particular and are expected to meet all other applicable regulatory requirements.

Specifically, section 206 of the MDUFMA amended the Act section 502(f) (21 USC 352(f)) by adding at the end of this section the following:

Required labeling for prescription devices intended for use in health care facilities may be made available solely by electronic means provided that the labeling complies with all applicable requirements of law and, that the manufacturer affords health care facilities the opportunity to request the labeling in paper form, and after such request, promptly provides the health care facility the requested information without additional cost.

If you have questions or concerns about electronic labeling, please contact James Woods, Deputy Director of the Office of In Vitro Diagnostics, at 301-594-3084.