Michael Kasser at Hogan Lovells

FDA spells out electromagnetic compatibility info needed in medical device premarket submissions

The U.S. Food and Drug Administration (FDA) recently issued the final guidance, “Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug Administration Staff,” which details the...more

6/22/2022 / Cybersecurity , Final Guidance , Food and Drug Administration (FDA) , Health Care Providers , Life Sciences , Manufacturers , Medical Devices

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

New draft guidance on MR compatibility for medical devices

The U.S. Food and Drug Administration (FDA) has published a new draft guidance titled "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." ...more

8/13/2019 / Comment Period , Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Regulatory Agenda , Regulatory Oversight , Rulemaking Process

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to streamline premarket review of medical devices, on April 12, 2018, the Food and Drug Administration (FDA) issued a draft guidance seeking to expand use of the historically underutilized...more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 Finalizes De Novo Evaluation Guidance and Issues Associated Refuse to Accept Checklist

On October 30, 2017, the Food and Drug Administration (FDA or the Agency) released its final De Novo request guidance document entitled, De Novo Classification Process (Evaluation of Automatic Class III Designation) (Final...more

11/17/2017 / De Novo Standard of Review , Final Guidance , Food and Drug Administration (FDA) , Medical Device User Fee Program (MDUFA IV) , Medical Devices , User Fees

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

Michael Kasser

Hogan Lovells

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