Guidance Documents (Medical Devices and Radiation-Emitting Products) Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays

Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays

This guidance document is being distributed for comment purposes only.
Document issued on: September 28, 2010

Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Alternatively, electronic comments may be submitted to http://www.regulations.gov.disclaimer icon All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this document contact Haja Sittana El Mubarak, Ph.D., Division of Microbiology Devices at 301-796-6193 or by email: HajaSittana.ElMubarak@fda.hhs.gov,

download pdf file:
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM227597.pdf

full-text:
Guidance Documents (Medical Devices and Radiation-Emitting Products) Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays