WHO Publishes Policy Considerations to Improve Access to Refractive Error Care
WHO has published policy considerations to improve access to refractive error care, focusing on spectacles, service access, workforce capacity, population education, cost reduction, surveillance and research.
FDA Issues Draft Guidance on Compliance Policy for Certain NIOSH-Approved Respirators
FDA releases draft guidance proposing reduced regulatory requirements for certain NIOSH-approved respirators. Understand the impact on medical device manufacturers.
MDCG 2020-16 Rev. 4: Update on the Classification of In Vitro Diagnostic Devices (IVDs)
MDCG has published Revision 4 of MDCG 2020-16, updating the classification of in vitro diagnostic medical devices (IVDs) in accordance with IVDR Regulation (EU) 2017/746. Among the main changes is the reclassification of SARS-CoV-2 tests. In addition, adjustments have been made to the classification of blood, tissue and organ screening tests, as well as clarifications for complementary diagnostics and self-tests.