QUOTED. July 23, 2018. Anne Gaynor.
The US FDA Blood Products Advisory Committee has recommended the down-classification of many HIV tests. See what Anne Gaynor, manager of HIV, Hepatitis, STD and TB programs at the Association of Public Health Laboratories (and a member of the committee) said about it here.
"The decision to regulate these devices under class III controls was made decades ago when little hope could be offered to those who became infected with these debilitating viruses, and in the case of HIV, diagnosis equated to a death sentence. Since that time we have made significant gains in our knowledge about these viruses and our ability to treat the infections they cause through research and epidemiological studies." –Anne Gaynor, manager of HIV, Hepatitis, STD and TB programs, Association of Public Health Laboratories
- Find out more:FDA Panel Backs Eased HIV Test Regs
Click here for a free trial of Medtech Insight