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
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
Key takeaways - FDA is soliciting feedback on a proposed framework to change medical device labeling to require long-term devices to identify all constituent materials that might come into contact with human tissue and to...more