Alexander,
FDA published a general memorandum G03-1 March 2003 that explains that MDUFMA changes the requirements in Section 502 to allow electronic labelling of prescription devices. Some text from the memorandum that basically boils down the requirement:
'Section 206 of MDUFMA amended Section 502(f) of the Federal Food, Drug, and Cosmetic Act (the Act) to authorize the use of electronic labeling, rather than the traditional paper labeling, under specified circumstances. Upon enactment, distributors of prescription devices who intend those devices to be used within the confines of a health care facility may provide labeling for those devices solely in electronic form, so long as they afford users the opportunity to request the labeling in paper form and promptly provide such labeling to requestors without additional cost.'
To answer your question the statement about labelling complying with regulatory requirements is that some companies think because it electronic is easier to maintain they can have additional information or just have the labelling be "dynamic" that in essence an IFU would not be controlled on say a website. The regulatory requirements mean that basically just as you would do for a paper version of the IFU, the same process would be followed for an electronic, including any current requirements such as revision control, content, UDI, safety, and claims being made. There has been thoughts reaching back to 2016 also that FDA would have a central database for company's IFUs, especially for Class III devices, but have not heard anything recent about that.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 07-Sep-2018 11:06
From: Alexander Schwiersch
Subject: elabeling - electronic user guides in the US
Dear Community,
when looking at the regulation in the US regarding 'elabeling', I came across this one and I would be interested in your opinion regarding specific examples of what this refers to:
[Section 502(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)) and similar: Baseline of the FD&C act 352(f)]
"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 [...]"
The scenario would be providing instructions for use no longer as a leaflet or book in paper format, but make them accessible via a webpage (to view and for download, print + paper copies will be provided on request).
So what is to be considered to ensure that labeling complies with all applicable requirements of law for this change of medium and distribution
model?
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Alexander Schwiersch
Munchen
Germany
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