The FDA reported a new streamlined pathway for diagnostic testing as part of a serial testing program using pooled samples, a pathway that should enable the further reopening of the economy. However, the FDA’s Tim Stenzel said April 21 that this new pathway relied on accumulated data for molecular testing, and that the agency lacks sufficient data to provide a similar mechanism for this use of antigen tests.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA provides path for diagnostic testing using pooled samples; FDA inks warnings for pandemic testing; Recall issued for repaired infusion pumps; NICE launches transformative strategy; NICE launches transformative strategy; Russia expands access to certain pediatric treatments.