Robert Friedman

King & Spalding

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Latest Posts › Medical Devices

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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

FDA’s Focus on Devices Impacting Women’s Health is Fully Underway: Breast Implant Advisory Set for March 25-26

Late last year, the Food and Drug Administration’s (FDA’s) Device Center announced a new objective when it comes to devices – “ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and...more

2/22/2019 / Advisory Committee , Food and Drug Administration (FDA) , Health Care Providers , Healthcare , Life Sciences , Manufacturer Liability , Manufacturers , Medical Devices , Pharmaceutical Industry

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