Australia’s Therapeutic Goods Administration (TGA) has published guidance on the transitional arrangements for the reclassification of certain medical devices. The guidance follows a consultation that ...
On Jan. 31, 2020, the Department of Health and Human Services (HHS) declared a public health emergency (PHE) related to the global COVID-19 pandemic. The declaration of a PHE enabled FDA to issue a ...
India’s Central Drugs Standard Control Organization (CDSCO) has set out the revised timelines for the move of some devices to a new regulatory framework. CDSCO had originally planned to transition the ...
On February 22, 2022, the U.S. Food and Drug Administration (FDA) hosted a webinar on two draft guidance documents for the transition plans for medical devices commercialized pursuant to either ...
These policies are all currently set to expire on November 7, 2023, which is 180 days after May 11, 2023. The Enforcement Policy Transition Guidance sets out three phases: Phase 1 (first 90 days after ...
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