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IFU Contact Requirements - FDA and MDD/MDR

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Ed Panek

Ed Panek

QA RA Small Med Dev Company
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#1
#1
For the requirements for FDA and CE what are the contact requirements for the IFU?

Website?
Phone contact?
Email?
Address?

Thanks,

Ed
 
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#2
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I believe that for FDA, only the address is required. However, you also need to consider the requirements that come from the ISO standards applicable to your product. For example, ISO 14630 requires a phone number. Of course, if you decide to do an electronic IFU available through a website, you must provide the website on the device label.
 
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