1. Principles of FDA Regulation for In Vitro Diagnostic Tests for Home Use Carol C. Benson OIVD/CDRH/FDA March 9, 2011 Molecular and Clinical Genetics Panel for Direct-to-Consumer (DTC) Genetic Tests

2. Examples of home use test Benefits Risks Interpretation of results Device performance Labeling Human factors Overview

3. Examples of Home Use Tests FDA Regulates TestCollect sample Perform test Interpret results GlucoseYes PregnancyYes Drugs of abuseYes Breath alcoholYes Ovulation and Menopause Yes

4. Examples of Home Use Tests FDA Regulates (Continued) TestCollect sample Perform test Interpret results Collection Hep. C kit YesNo Collection HbA1c kit YesNoYes Collection HIV-1 kit YesNo And others …but “No” genetic tests

5. What are the Benefits for Home Use Tests?  Condition/disease that needs to be monitored at home?  Diabetes – home glucose meters monitor the management of diabetes home user under care of a physician  Not for diagnosis – no performance

6. What are the Benefits for Home Use Tests?  Condition/disease that can be identified to allow for early detection at home?  Pregnancy – urine hCG tests  users retest, go to HCP

7. What are the Benefits for Home Use Tests?  Condition/disease that can be screened for at home?  Drug detection – Home DOA urine test  Not a definitive test  Mitigation - send sample for confirmation testing

8. What are the Risks of Home Use Tests?  Is the device robust?  Simple to use  Works correctly every time  Not affected by environmental conditions or different operators  Can a home user read instructions and  Collect the sample correctly  Perform the test  Get accurate results and interpret results

9. Interpretation of the Results to Ensure Safe and Effective Use Does the home user know what to do with the results?  Test again on another day  Collect another sample and retest  Contact HCP – seek treatment  Not seek treatment  Not suspect the test may be wrong

10. What are the Risks of False or Inaccurate Results at Home?  Failure to seek treatment  Delay in seeking treatment  Improper self management/treatment  No follow up with health care provider  Unnecessary worry  False sense of security

11. Do the benefits outweigh the risks? If yes, then…

12. Evaluate Performance of the Test in the Hands of the Intended User: Home User Study  Compare home user results to laboratory method  How well the test should work at home depends upon benefit and mitigation of risks  Likelihood of incorrect results

13. Does the labeling provide adequate information so home user can perform the test and interpret the results for safe and effective use? Labeling

14. How Does FDA Review Labeling for Home Use Tests?  Written at 8 th grade reading level  Simple instructions  Pictures and diagrams on how to get sample and perform test  Clear instructions on how to interpret the results (what to do with the results – call HCP – retest)  Users know when device did not work  User know what to do if device does not work  Telephone number to call for assistance

15. How Do Human Factors Play a Role in Home Tests?  People have different abilities to follow directions  Home users are not trained users so no “good laboratory practice” standard for them  Fail to get adequate or appropriate sample  Can perform test incorrectly  Can interpret results incorrectly

16. Summary – FDA Principles for Regulation of Home Use Tests  FDA regulates home use tests  Benefits vs. risks  Mitigation of risks  Interpretation of results by home user  Performance of the device by home user  Labeling  Human factors

17. http://www.accessdata.fda.gov/scripts/cdr h/cfdocs/cfIVD/Search.cfm Website for Database Search for Home Use Tests:

18. 18 Thank You! Carol.Benson@fda.hhs.gov