FDA Exempts 1,003 Class II Devices From 510(k) Regs
The FDA finalized its list of 1,003 class II medical devices low-risk enough to be exempt from 510(k) requirements.
The list is part of the agency’s implementation of a 21st Century Cures Act provision that aims to reduce devicemakers’ regulatory burden. The device types on the list were deemed a sufficiently low-risk not to require a premarket notification review to determine safety and effectiveness.
The agency noted, however, that the devices on the list are not exempt from other regulations or requirements unless that exemption is specifically established by another law or order. All devices, exempt and otherwise, are subject to current device GMPs, packaging and labeling rules, and regulations on intended use.
FDA Develops Ebola Vaccine Response Assay
Scientists at the FDA announced the development of a new assay to analyze antibody response to Ebola virus vaccinations that does not require the use of the virus.
Rather than the live Ebola virus, the assay relies on a genetically modified, non-disease-causing virus called vesicular stomatisis virus, which shares part of the Ebola genome.
The lack of the actual virus means the process can skip several additional precautions, such as a BSL-4 laboratory, which is normally required for developing vaccinations for pathogens such as the Ebola virus. The new assay can be used in lower-security, more widely available BSL-2 laboratories.