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Guidelines and Codes

Guidance for Over-the-Counter Pregnancy Test Kits

Added to web site: October 2003

Medsafe wishes to announce that they have adopted the FDA Guideline; Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG).

This can be read in full at www.fda.gov/cdrh/ode/guidance/1172.html

The key points likely to affect industry with regard to pregnancy test kits for OTC sale in NZ are as follows:

1.  Accuracy claim, based on test efficiency, should never exceed 99%.
2. Sensitivity/Detection Limit is 25mIU/mL
3. The label/advertising may state that the test is capable of detecting pregnancy by the first day of the missed period and no sooner, unless validated by clinical data.
4. The package insert should be concise, easy to understand, and contain clear illustrations and drawings.