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FDA Requires “Patient-Decision Checklists” for Breast Implants: What Could This Mean for Industry?

USA - November 22 2021 The FDA announced on October 27, 2021, that it will restrict the sale of breast implants to healthcare providers and facilities that use a…

Jonathan S. Tam, Katherine Unger Davis, Justin M. Kadoura, Marina Schwarz

FDA’s Proposal For Listing Materials on Medical Device Labeling: Considerations for Industry

USA - July 16 2021 On May 20, 2021, FDA’s Center for Devices and Radiological Health published a Discussion Paper entitled “Conveying Materials Information about…

Sheila L Birnbaum, Katherine Unger Davis, Emily Van Tuyl