Kelliann Payne

Hogan Lovells

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FDA finalizes cyber device “select updates” guidance, potentially affecting substantial equivalence findings for 510(k)s

The U.S. Food and Drug Administration (FDA) recently finalized its March 2024 select updates to its guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (“Premarket...more

7/7/2025 / Cybersecurity , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , New Guidance , New Regulations , Regulatory Requirements , Risk Management , Software

FDA finalizes 2025 Q-Submission Guidance, streamlining interactions for device sponsors and proposes electronic submission mandate...

On May 29, 2025, the U.S. Food and Drug Administration (FDA) issued a final version of its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” offering an expanded framework...more

6/17/2025 / Draft Guidance , Filing Requirements , Final Guidance , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , New Guidance , Proposed Rules , Regulatory Oversight , Regulatory Requirements

FDA finalizes 3D printing guidance

On December 5, 2017, the U.S. Food and Drug Administration (FDA or the Agency) finalized its “leapfrog guidance” entitled, “Technical Considerations for Additive Manufactured Devices”. ...more

12/21/2017 / 3D Printing , Additive Manufacturing , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , New Guidance , Pharmaceutical Industry , Technology Sector

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