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GUIDANCE DOCUMENT

Acceptable Media for Electronic Product User Manuals Guidance for Industry and FDA Staff August 2024

Download the Final Guidance Document
Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

FDA is issuing this guidance 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.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-0957.

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