ENFORCEMENT

FDA Sends 14 Warning Letters Regarding Cancer Products

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

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

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

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

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

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

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

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

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

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...]


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