Katherine Unger Davis

Dechert LLP

Articles

Results 1 to 3 of 3


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, Justin M. Kadoura, Marina Schwarz, Sharon Turret

FDA Committee Looks to Car Industry as Potential Model for Medical Device Recalls

USA - October 20 2021 What do medical devices have in common with cars? As the FDA, patient advocacy groups, and industry struggle with how best to communicate device…

Jacqueline Harrington, Justin M. Kadoura, Rachel Passaretti-Wu

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, Sharon Turret, Emily Van Tuyl