FDA Draft Guidance on Section 524B: Overview
The article provides an overview of the regulatory approach to be applied concerning certain regulatory matters.
The article provides an overview of the regulatory approach to be applied concerning certain regulatory matters.
The article highlights the critical points of managing new submissions related to the products intended to be placed on the Canadian market.
The article highlights the critical points related to the recall procedures applicable to medical devices allowed for marketing and use in Canada.
The new article clarifies the recall procedure in the context of the roles and responsibilities of the parties involved.
The new article describes in detail the recall process, highlighting the most important aspects associated with it.
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