Hi Yuanyuan,
I agree with John that purchasing the standards is not enough. There are many factors to consider, such as your company size, number of products, system, databases, and software that your company is using.
You need to perform a UDI impact and comply with the following regulations:
21 CFR 801 - Labeling, 803 – Medical Device Reporting, 806 - Recalls, 810 – Medical Device Recall Authority, 814 – Premarket Approval of Medical Devices, 820.120 – Device Labeling, 820.184 – Device History Record, 820.198 – Compliant Files, 820.200 - Servicing, 821 – Medical Device Tracking Requirements, and 822 – Post-Market Surveillance.
For barcodes, are you going to use one-dimensional (1D) or two-dimensional (2D) barcodes? The UDI rules need to be implemented by doing some preliminary testing of business rules, documents, packaging, workflows, etc. Then, you need to identify the parameters needed for 1D or 2D barcodes, webscan unit, workflows with barcode verifier steps, webscan validation, modifications, etc.
Your company product’s labels, drawings, and artworks that incorporate the FDA UDI requirements need to be updated.
I hope the above helps,
Aurelia Brownridge
Sr. Regulatory Affairs Specialist
Illumina
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Aurelia Brownridge
Sr. Regulatory Affairs Specialist
Illumina
San Diego CA
United States
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Original Message:
Sent: 06-Apr-2017 09:18
From: John Minier
Subject: UDI Label Verification, Part 830.20 requirement
Hi, Yuanyuan,
It is not enough to purchase the standards. You must comply to the AIDC verification standards. Your company can purchase bar code scanners with verification software or engage a vendor that complies with the standards to print and verify the labels for you.
Regards,
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John Minier, RAC
Consultant, Principal
Minier Medical Device Consulting
john@johnminier.com
1(914)850-4432
Highland Mills, NY
United States
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Original Message:
Sent: 05-Apr-2017 16:38
From: Yuanyuan Yu
Subject: UDI Label Verification, Part 830.20 requirement
Hello,
I am doing UDI labeling verification and wonder if anyone has experience to comply with Part 830.20 requirement.
FDA 21 CFR 830.10 states the following requirements for UDI:
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.
I am a little confused how manufacture can verify section (b) compliance? Can I simply say that our firm has purchased these standards?
Many thanks!
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Echo Yu
Regulatory Associate
echo.yu@sciex.com
71 Four Valley Drive
Concord, ON L4K 4V8 Canada
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