Understanding and Avoiding Compliance Errors
Know where labs may fall foul of compliance requirements—and discover the actions your lab can take to mitigate the risk of noncompliance
Keeps You Up-to-Date on Federal & State Laws, Regulations, New Legislation, and Court Cases that Affect Your Diagnostic Lab or Pathology Practice
Know where labs may fall foul of compliance requirements—and discover the actions your lab can take to mitigate the risk of noncompliance
From - National Intelligence Report
After facing federal and state government scrutiny for more than a year, Theranos has reached agreements with the Centers for Medicare & Medicaid Services (CMS) and the Arizona Attorney General to…
From - National Intelligence Report
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 that…
From - National Intelligence Report
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…
From - National Intelligence Report
House of Representatives members Larry Bucshon, M.D. (R-IN) and Diana DeGette (D-CO) are looking for feedback on a discussion draft of legislation called the…