The US Food and Drug Administration wants to make permanent a previous guidance that requires medtech manufacturers and distributors to notify the agency of a product shortage during a public health emergency. The previous November 2020 guidance expires with the COVID-19 pandemic health emergency, but the agency wants to make sure it stays in place for future emergencies.
According to the draft guidance published on 10 January, device and diagnostics makers would need to notify the FDA through its website at least a month before a shortage...