Guidance for Industry and FDA Staff
Acceptable Media for Electronic Product User Manuals
Document issued on: March 18, 2010
FDA has developed this guidance document to allow manufacturers to provide user manuals accompanying electronic products in either paper or electronic form. This is done to recognize that electronic media are now being widely used to provide instruction, while at the same time reducing paper consumption, increasing accessibility and providing rapid means for editing and updating content.
The Code of Federal Regulations (CFR) Title 21 Part 1002.3 states in part: “The Director… of the Center for Devices and Radiological Health… may require a manufacturer of a radiation emitting electronic product to provide to the ultimate purchaser…performance data and other technical data related to safety of the product…” These data are typically contained in user manuals that accompany electronic products and historically the media for these manuals has been printed paper. Specific performance standards in 21 CFR Parts 1020.20(c)(4)(i), 1020.30 (h), 1020.40 (c)(9), 1030.10(c)(4), 1040.10(h), 1040.20(e), and 1050.10(f)(2) also contain requirements for providing instructions to users of electronic products. For example, 21 CFR 1020.30(h) and 1040.10(h) specify information manufacturers must provide to users of diagnostic x-ray and laser products respectively.
With the availability of electronic information storage and display technology, many commercial product manuals are being provided electronically. Electronic documentation saves storage space, reduces paper consumption, increases accessibility, and provides rapid means for editing and updating of content.
For these reasons, the Center for Devices and Radiological Health (CDRH) will allow manufacturers to provide the required user information in a commonly used electronic format (e.g. Adobe Acrobat or Rich Text Format). Manufacturers may provide the required information as a web site download, on a compact disc (CD) or on other storage media in common use (e.g. USB external drive), so long as it is made available directly to the purchaser of the product. If the product purchaser is unable to access the electronic version provided, the manufacturer must make the required documentation available in hard copy (e. g. printed paper) at no additional cost. The manuals in whatever form provided should be in the English language.
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Last Updated: 2015-12-18