References

1.      Food and Drug Administration (FDA). Classify Your Medical Device. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm2005371.htm. Accessed November 24, 2015.

2.      Food and Drug Administration (FDA). Laboratory Developed Tests. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm407296.htm. Accessed November 24, 2015.


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3.      23andMe. An Update Regarding The FDA’s Letter to 23andMe. http://blog.23andme.com/news/an-update-regarding-the-fdas-letter-to-23andme/. Accessed November 24, 2015.

4.      Food and Drug Administration (FDA). Untitled Warning Letter. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm. Accessed November 24, 2015.

5.      Food and Drug Administration (FDA). FDA Permits Marketing of First Direct-to-Consumer Genetic Carrier Test for Bloom Syndrome. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm435003.htm. Accessed November 24, 2015.

6.      23andMe. 23andMe Launches New Customer Experience. http://mediacenter.23andme.com/blog/2015/10/21/new-23andme/. Accessed November 24, 2015.

7.      Carreyrou, J. Hot Startup Theranos Has Struggled With Its Blood-Test Technology. Wall Street Journal. http://www.wsj.com/articles/theranos-has-struggled-with-blood-tests-1444881901. October 16, 2015. Accessed November 24, 2015.

8.      Theranos. Theranos Receives CLIA Waiver, Paving the Way for Greater Accessibility of Health Information at the Time and Place it Matters. https://www.theranos.com/news/posts/theranos-receives-clia-waiver-paving-the-way-for-greater-accessibility-of-health-information-at-the-time-and-place-it-matters. Accessed November 24, 2015.

9.      Food and Drug Administration (FDA). Untitled Document. http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm469395.pdf. Accessed November 24, 2015.

10.   Theranos. Statement From Theranos. https://www.theranos.com/news/posts/statement-from-theranos-2. Accessed November 24, 2015.

11.   Food and Drug Administration (FDA). Untitled Warning Letter. http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM471785.pdf. Accessed November 24, 2015.

12.   Food and Drug Administration (FDA). The Public Health Evidence for FDA Oversight of Laboratory Developed Tests. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM472777.pdf. Accessed November 24, 2015.