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SPECIAL CONTROLS DOCUMENT

Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays Guidance for Industry and FDA Staff August 2011

Final
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.