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:
- Accuracy claim, based on test efficiency, should never exceed 99%.
- Sensitivity/Detection Limit is 25mIU/mL
- 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.
- The package insert should be concise, easy to understand, and contain clear illustrations and drawings.