FDA sets up webpage, template for screening
The U.S. FDA posted a new webpage on the agency’s website dedicated to screening for the SARS-CoV-2 virus, intended as a resource for schools and workplaces that seek to establish protocols for screening. The webpage explains the difference between diagnostic and screening test intended uses, and offers advice for screening protocols. The agency also released a supplemental template for development of both molecular and antigen tests for serial testing protocols for screening, which suggests that a test’s intended use statement indicate that testing should take place no more frequently than every 24 hours and no less frequently than twice every three days. Other testing frequency/intervals may be permitted for tests with higher sensitivity. The agency said it would consider granting an emergency use authorization for point-of-care and at-home tests, including over-the-counter tests, when the candidate test exhibits a positive percent agreement of at least 80%.
Stryker’s STAR ankle exhibiting fracture risk
The FDA said its data suggest a higher-than-expected risk of fracture in the polyethylene components of the Scandinavian Total Ankle Replacement (STAR) device by Stryker Corp., of Kalamazoo, Mich. The agency said the adverse event data indicate that fracture may occur within three to four years post-implant, which may require surgery to repair or replace the device. The data are in part drawn from a post-approval study of the STAR, and indicate that the risk is distributed across all STAR units regardless of manufacture date. Older and more sedentary patients may be appropriate candidates for these devices while patients younger than 55 years of age, those with osteoarthritis and those with active lifestyles have an elevated fracture risk.