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U.S. Department of Health and Human Services

For Industry

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Draft Guidance for Industry and FDA Staff- Humanitarian Use Device (HUD) Designations

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This draft guidance document is being distributed for comment purposes only.
 
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be submitted within _90_ days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 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.  All comments should be identified with the docket number [FDA-2011-D-0847] listed in the notice of availability that publishes in the Federal Register.
 
For questions regarding this draft document contact:
 
Mr. Eric Chen
301-796-6327
 
 
 

 

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