Michael Kasser

Hogan Lovells

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Latest Posts › Pharmaceutical Industry

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FDA finalizes guidance on non-clinical assessment of medical devices containing nitinol

The U.S. Food and Drug Administration (FDA) has finalized their guidance related to medical devices that contain nitinol, the draft of which was published on April 19, 2019. The guidance recommends that companies clarify the...more

10/28/2020 / ASTM , Clinical Laboratory Testing , FDA Approval , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry

Seeking to reduce premarket burdens, FDA proposes to expand Abbreviated 510(k) Pathway for certain devices

Building on recent efforts to streamline premarket review of medical devices, on April 12, 2018, the Food and Drug Administration (FDA) issued a draft guidance seeking to expand use of the historically underutilized...more

4/19/2018 / 510(k) RTA , FDA Approval , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry , Premarket Approval Applications

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

FDA Embraces Real-World Evidence in New Final Guidance

On August 31, 2017, the U.S. Food and Drug Administration (FDA) finalized its guidance document entitled, "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices." The final guidance reiterates...more

9/18/2017 / Decision-Making Process , FDARA , Food and Drug Administration (FDA) , Medical Devices , New Guidance , Pharmaceutical Industry , Regulatory Standards

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