The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Guidance for Industry Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay

Origin/Publisher:

Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/

Document Type:
Guidance for Industry
Content:
In this document, we describe two pathways for you to seek clearance of your assay as a Class II device for detecting HIV mutations. Under the first pathway, you would demonstrate the analytical sensitivity of your test in identifying mutations in Tables A through E, below. An applicant following the second pathway would develop a combination of analytical data and clinical data showing the performance of the test as an aid in treatment of subjects with HIV. We recognize that as the field progresses, additional mutations may become widely recognized as clinically significant. We have based the information in this document on current science.

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK