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

After two years of consideration, the FDA has restricted the sale of breast implants to healthcare providers that use an FDA-approved patient-decision checklist to discuss the benefits and risks of the implants with patients....more

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

Key Takeaways - The FDA’s Patient Engagement Advisory Committee, organized under the Center for Devices and Radiological Health (“CDRH”), held a public meeting on October 6, 2021, to discuss issues surrounding the...more

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