The FDA’s Reclassification of IVDs and Implications for LDTs Posted on March 22, 2024 (March 22, 2024) by Andy Chasteen […] Read More… from The FDA’s Reclassification of IVDs and Implications for LDTs
MDC Welcomes Matthew Faron, PhD Posted on March 7, 2024 (March 7, 2024) by Andy Chasteen […] Read More… from MDC Welcomes Matthew Faron, PhD
Updates from Jan 2024 CLSI AST Subcommitee and Working Groups Posted on February 20, 2024 (February 21, 2024) by Andy Chasteen […] Read More… from Updates from Jan 2024 CLSI AST Subcommitee and Working Groups
EU Commission Proposes Extension of IVDR Compliance Deadlines Posted on January 30, 2024 (January 30, 2024) by Andy Chasteen […] Read More… from EU Commission Proposes Extension of IVDR Compliance Deadlines
FDA and CMS Reject the Notion of Expanding CLIA to Oversee LDTs Posted on January 23, 2024 (January 24, 2024) by Andy Chasteen […] Read More… from FDA and CMS Reject the Notion of Expanding CLIA to Oversee LDTs
FDA’s Proposed Regulations for Laboratory Developed Tests Posted on January 11, 2024 (January 11, 2024) by Andy Chasteen […] Read More… from FDA’s Proposed Regulations for Laboratory Developed Tests
MDC Associates selected as a spoke of ARPA-H Investor Catalyst Hub network Posted on December 15, 2023 (January 11, 2024) by Andy Chasteen […] Read More… from MDC Associates selected as a spoke of ARPA-H Investor Catalyst Hub network
Breakthrough Devices: Recent Changes and Expanding Initiatives by FDA Posted on October 31, 2023 (January 11, 2024) by Andy Chasteen […] Read More… from Breakthrough Devices: Recent Changes and Expanding Initiatives by FDA
Registering and Listing Your Medical Devices for 2024 Posted on October 6, 2023 (October 6, 2023) by Andy Chasteen […] Read More… from Registering and Listing Your Medical Devices for 2024
Shutdown and Impacts on U.S. FDA Averted For Now Posted on September 30, 2023 (October 2, 2023) by Andy Chasteen […] Read More… from Shutdown and Impacts on U.S. FDA Averted For Now