Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays
This special controls guidance document was developed to support the reclassification of the herpes simplex virus types 1 and 2 (HSV 1 and 2) serological assays into class II.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.