Yes, in vitro diagnostic (IVD) devices marketed in the United States are generally required to comply with ISO 13485, which is the international standard for quality management systems (QMS) specific to medical devices, including IVDs.

While the U.S. Food and Drug Administration (FDA) does not explicitly mandate ISO 13485 certification for all IVD devices, manufacturers must establish and maintain a QMS that meets the FDA's requirements under 21 CFR Part 820. ISO 13485 is widely accepted as a framework that aligns with these FDA regulations, making it a common practice for manufacturers to implement ISO 13485 to demonstrate compliance.

Additionally, ISO 13485 certification can help with regulatory submissions and facilitate easier market entry in other countries, as many global markets recognize it as a standard for medical device manufacturing.

To summarize:

• ISO 13485 is not a legal requirement in the U.S. for IVD devices, but it aligns with FDA's QMS regulations.
• It is highly recommended and commonly used to ensure compliance with both FDA regulations and international standards.

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