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On September 7, 2023, FDA issued three new draft guidance documents intended to strengthen the 510(k) premarket notification pathway for medical devices.
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July 25, 2011 Practices: FDA Regulatory, Advertising & Promotion, Congressional Investigations & Public Policy, Due Diligence Reviews & Transactional Support, FDA Enforcement Actions & Litigation, Post-Approval Compliance, Regulatory Strategy, Product Development & Product Approvals
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