FDA 21 CFR 830.20 states the following requirements for UDIs:
Question is regarding the ISO/IEC 15459 requirements.
I'm not familiar with these standards. Are there any surprises here?
...or if you're following the specifications of a particular FDA-accredited agency (e.g. GS1), is it reasonable to assume the requirements of these standards are met?
A unique device identifier (UDI) must:
(a) Be issued under a system operated by FDA or an FDA-accredited issuing agency;
(b) Conform to each of the following international standards:
(1) ISO/IEC 15459-2, which is incorporated by reference at ?830.10;
(2) ISO/IEC 15459-4, which is incorporated by reference at ?830.10; and
(3) ISO/IEC 15459-6, which is incorporated by reference at ?830.10.
(c) Use only characters and numbers from the invariant character set of ISO/IEC 646, which is incorporated by reference at ?830.10.
(a) Be issued under a system operated by FDA or an FDA-accredited issuing agency;
(b) Conform to each of the following international standards:
(1) ISO/IEC 15459-2, which is incorporated by reference at ?830.10;
(2) ISO/IEC 15459-4, which is incorporated by reference at ?830.10; and
(3) ISO/IEC 15459-6, which is incorporated by reference at ?830.10.
(c) Use only characters and numbers from the invariant character set of ISO/IEC 646, which is incorporated by reference at ?830.10.
I'm not familiar with these standards. Are there any surprises here?
...or if you're following the specifications of a particular FDA-accredited agency (e.g. GS1), is it reasonable to assume the requirements of these standards are met?