FDA 510K，工厂生产地址变更

Nana~~

FDA 510K，工厂生产地址变更，需要注册变更吗，还是内部变更就可以了

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yuqman

找了一个文件可以参考一下
Changes to a medical device or its processes vary in complexity. Some types of changes are
straightforward and will generally result in a decision that submission of a new 510(k) is not
required. To that end, a manufacturer may establish a documentation process that accommodates
different levels of documentation depending on the complexity of the change. Simple changes
would have simple documentation and may not necessarily go through each question in detail;
more complex changes should have more detailed documentation. Examples of types of changes
that can typically be documented with simple documentation include:
• Change of company labels to update to new company name, e.g., following acquisitions
or address changes
• Labeling layout changes where content is not changed, for instance, due to a corporate
rebranding initiative
• Addition of a unique device identifier (UDI) to labeling
• Raw material supplier changes that only modify the reference number or brand name of
raw materials and do not change the raw material itself
按照这里面的说法通常不用提交510K