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Click ‘Get Form’ to open it in the editor.
Begin by reviewing the Executive Summary section. This provides an overview of the document's purpose and key arguments regarding the replacement of FDA regulation with third-party certification.
Proceed to fill out any required fields in the Introduction section, summarizing your understanding of the FDA's role and its implications on medical device access.
In the Nature of the Problem section, articulate specific issues caused by FDA delays. Use bullet points for clarity if applicable.
Address each component under The Alternative and Third-Party Certification sections, ensuring you highlight how these solutions can improve market access for medical devices.
Conclude by summarizing your insights in a final remarks section, emphasizing the benefits of third-party certification over FDA regulation.
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