First, please define what you mean by an RUO company. In my experience there are different types. One makes products for research in a lab, but the products are not used for diagnosis in humans. For example, the product might be used to study metabolic pathways in mice. Here the ROU designation indicates that it is not intended for diagnosis in humans.
The other is developing an IVD (for diagnosis in humans), and the development is in the research stage. This is covered by the RUO designation in 21 CFR Part 809. They are labeled as required by the FDA regulation so they may be legally shipped in interstate commerce.
You say the company makes lateral flow devices. This implies, especially the word device, that these are medical devices intended for diagnosis in humans and, as such, cannot be an RUO product.
The first case (major changes) is a bad practice since the change may affect the ability to compare the results obtained for prior versions. In addition, you need to know if customer has specified change notification.
The other two cases are not in compliance with ISO 13485:2016. An auditor (first, second, or third party) would write a nonconformance. A third party auditor would likely revoke your certificate for repeat problems.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 29-Apr-2024 09:54
From: Anonymous Member
Subject: Ethical and Regulatory Compliance Concerns in a RUO Company with ISO 13485 Certification
This message was posted by a user wishing to remain anonymous
Dear All,
I would greatly appreciate everyone's input on the following matter:
Is it permissible for a RUO (Research Use Only) company, which specializes in the design, development, and manufacture of lateral flow devices and holds ISO 13485 certification, to engage in the following practices:
- Implementing major changes to devices and selling them to customers without providing any notification about the alterations.
- Shipping products to customers before undergoing review and approval processes, including batch record closure and quality control testing by the QA department.
- Retroactively altering documents as needed by management.
Are these activities considered acceptable due to the RUO classification of the company? Additionally, how do these practices align with ISO 13485 standards?
It's important to note that the company is controlled and managed by an individual other than the CEO, who is located in a different country and may not be aware of these specific issues.
THANKS.