CDRH has posted a new policy that permits manufacturer's User Manuals for radiation-emitting electronic products to be provided to purchasers in electronic form. See guidance posted on the Radiological Health Program website here: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm205782.htm
FDA has developed this guidance document to allow manufacturers to provide user manuals accompanying electronic products in either paper or electronic form. 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.
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) Electronically using FDA’s eSubmitter software. Documents prepared using eSubmitter may be sent directly to CDRH via FDA’s Electronic Submissions Gateway (ESG).
2) On CD using FDA’s eSubmitter software. Documents prepared using eSubmitter may be loaded on a CD and mailed to CDRH for processing, or
3) In hard copy
Note: FDA will not accept electronic versions of user manuals unless the required radiation safety report is also submitted electronically.