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FDA Proposes New 510(k) Process to Ensure Application Completeness Featured
Written by Jaimie Oh | August 13, 2012
The FDA has proposed a new checklist to ensure device companies' submissions for product approvals are complete with required administrative elements.
The federal agency's recommendations are part of its efforts to streamline the 510(k) review process in exchange for doubling fees companies must pay to submit applications. The proposed checklist would ensure applications include several elements, such as table of contents or page numbers, and save the FDA's time spent on crafting letters requesting the missing information.
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