Acceptable Media for Electronic Product User Manuals: Guidance for Industry and FDA Staff
Published: 2024-08-19
Status: Final Type: Guidance Document Category: Radiation / Imaging Docket: FDA-2020-D-0957
Official Source
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptable-media-electronic-product-user-manuals PDF: https://www.fda.gov/media/78332/download
Official Full Text
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page. For these reasons, manufacturers can provide the required user information in PDF 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. 3. Impact on Required Reports Radiation safety reports (including user manuals) required by 21 CFR 1002.10 through 1002.13 may be submitted to FDA in one of the following ways: 1) All Radiation Safety reports may be submitted to CDRH by email to the RadHealthCustomerService@fda.hhs.gov mailbox. This includes all report types, such as product reports, annual reports, and supplemental reports of all types, and all communications such as notifications of defect/failure to comply, corrective action plan (CAP) proposals, and accidental radiation occurrences (AROs). Reports should be submitted in PDF format, or packaged by the eSubmitter packaging procedures, and attached to your email. eSubmissions no longer need to be transferred to a physical medium and mailed to the CDRH Document Control Center. An eSubmitter user does not need to acquire an FDA Electronic Submissions Gateway account. 2) Electronically using FDA’s eSubmitter software which can be downloaded at no cost from https://www.fda.gov/industry/fda-esubmitter. Documents prepared using eSubmitter may be sent directly to CDRH via FDA’s Electronic Submissions Gateway (ESG). 3) On CD using FDA’s eSubmitter software. Documents prepared using eSubmitter may be loaded on a CD and mailed to CDRH for processing, or 4) In hard copy, paper documentation may be mailed to the following address: U.S. Food and Drug Administration Center for Devices and Radiological Health Document Control Center - WO66-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 Note: If electronic versions of user manuals are submitted, the required radiation safety report should also be submitted electronically.