Susan Clare

King & Spalding

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NHTSA to Require Reporting of Crashes Involving SAE Automation Levels 2+

On June 29, 2021, the National Highway Traffic Safety Administration (NHTSA) issued a Standing General Order (SGO) to manufacturers and operators of Automated Driving Systems (ADS) and Level 2 Advanced Driver Assistance...more

7/12/2021 / Automotive Industry , Confidential Business Information (CBI) , Driverless Cars , Good Faith , Hardware , Manufacturers , NHTSA , Software

FDA Announces Updates to Two Guidance Documents Concerning Breast Implant Safety and Transparency

Maintaining its focus on breast implant safety, on September 28, 2020, FDA announced the issuance of the final guidance, “Breast Implants— Certain Labeling Recommendations to Improve Patient Communication,” (the “2020 Final...more

10/7/2020 / Food and Drug Administration (FDA) , Guidance Update , Labeling , Medical Devices

FDA Continues its Focus on Breast Implant Safety and Transparency with an Eye Toward Improving Regulatory Decision-Making

In an August 20, 2020, press release, the Food and Drug Administration (FDA) provided an update on the medical device reports (MDRs) received by the agency relating to breast implants, including breast implant-associated...more

9/1/2020 / Advisory Committee , Food and Drug Administration (FDA) , Medical Device Reports (MDRs) , Medical Devices , New Guidance , Transparency

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