Q
QARKM
For CE and FDA do I need the full street and ZIP/Postcode address on a medical device label or does a web address suffice?
Web Address or the Full Street and ZIP/Postcode Address for FPR Labeling?
chris1price
Trusted Information Resource
Hi
For Europe, it should be a postal address, with sufficient detail to allow a letter to be delivered. In UK, a company name, postcode and country will often be sufficient.
I dont think a Web or email address is acceptable for any regulatory body.
Chris
For Europe, it should be a postal address, with sufficient detail to allow a letter to be delivered. In UK, a company name, postcode and country will often be sufficient.
I dont think a Web or email address is acceptable for any regulatory body.
Chris
L
Laura Halper
Hi QARKM,
The FDA requirements for the U.S. are found in 21CFR 801.1(d):
"The statement of the place of business shall include the street address, city, State, and Zip Code; however, the street address may be omitted if it is shown in a current city directory or telephone directory...."
So just website or email address is not acceptable in the U.S., either.
Regards,
Laura
The FDA requirements for the U.S. are found in 21CFR 801.1(d):
"The statement of the place of business shall include the street address, city, State, and Zip Code; however, the street address may be omitted if it is shown in a current city directory or telephone directory...."
So just website or email address is not acceptable in the U.S., either.
Regards,
Laura
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