FDA issued final guidance Nov. 28 describing the types of clinical studies the agency recommends to support pre-market approval of human papillomavirus (HPV) tests, but noted that increases in HPV vaccination may be changing the testing landscape.
The final guidance largely mirrors a September 2009 draft, with minor tweaks. For instance, the document suggests additional substances for interference tests and includes a “statistical analysis appendix” with recommendations for performing statistical analyses, as requested by AdvaMed in comments on the draft
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?