The U.S. Food and Drug Administration (FDA) continues to focus on direct-to-consumer marketing and sale of products and has issued warning letters in an effort to protect vulnerable cancer patients … [Read more...]
FDA
FDA Exempts Certain Class I Devices, Test Kits from 510(k) Filing
May 17, 2017
The FDA has determined that 71 device types, including some diagnostic test kits, should be exempt from 510k filings. These devices are deemed "sufficiently well understood and do not present … [Read more...]
FDA
FDA Reports Advances in Diagnostics Development
May 2, 2017
The U.S. Food and Drug Administration (FDA) recently unveiled its FY 2015-2016: Regulatory Science Progress Report. The report, the second of its kind under the Food and Drug Administration Safety and … [Read more...]
FDA
23andMe Receives FDA Approval for DTC Genetic Test
April 26, 2017
23andMe and the U.S. Food and Drug Administration (FDA) recently announced that the agency allowed marketing of 23andMe's Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or … [Read more...]
FDA
FDA Reports “Significant Progress” in Diagnostics Development
April 26, 2017
The U.S. Food and Drug Administration (FDA) recently unveiled its FY 2015-2016: Regulatory Science Progress Report. The report, the second of its kind under the Food and Drug Administration Safety … [Read more...]
FDA
Reports Indicate Faster FDA Approval Processes
April 26, 2017
The U.S. Food and Drug Administration (FDA) is plagued with chronic understaffing, scrutiny over the length of time for approvals, and an expanding workload, while also facing potential budget cuts … [Read more...]
FDA
Test Kits Included in Class 1 Devices Exempt from 510k Filing
April 18, 2017
The FDA has determined that 71 device types, including some diagnostic test kits, should be exempt from 510k filings. These devices are deemed "sufficiently well understood and do not present risks … [Read more...]
FDA
FDA Grants Approval for 23andMe DTC Genetic Test
April 10, 2017
23andMe and the U.S. Food and Drug Administration (FDA) announced last week that the agency allowed marketing of 23andMe's Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or … [Read more...]
FDA
Flu Antigen Tests Reclassified as Class II Devices
February 27, 2017
Effective this month, the U.S. Food and Drug Administration (FDA) has reclassified antigen-based, rapid influenza virus antigen detection test systems (RIDTs) used directly on clinical specimens from … [Read more...]
LDTs
FDA Discussion Paper Synthesizes Stakeholder Feedback on LDT Regulation
January 23, 2017
Last December, the U.S. Food and Drug Administration announced that it would not finalize the guidance on agency oversight of laboratory developed tests (LDTs) that it proposed back in 2014— at least … [Read more...]
