Paper copies of Electronic labeling

The Medical Device User Fee and Modernization Act(MDUFMA), signed into law in the United States in October 2002, explicitly permits e-labeling for prescriptive devices (as defined in the amended Section 502(f) of the Federal Food, Drug, and Cosmetic Act) used in healthcare facilities. However, user may request at no charge paper copies of labeling/manuals. The text from MDUFMA is below and a memorandum from the Office of Device Evaluation for in vitro diagnostics that is also relevant is at the link provided:
Section 502(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)) is amended by adding at the end 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.”.

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