Document Detail


Development of PMA guidance for ventricular assist devices and total artificial heart.
MedLine Citation:
PMID:  18244064     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
The US Food and Drug Administration's (FDA's) involvement in the investigation of devices since 1980 is discussed. The development of draft guidelines for a premarket approval application (PMA) is described. The availability of the document is announced and comments are solicited.
Authors:
A Acharya
Related Documents :
11382584 - Implantable middle ear hearing devices: food and drug administration review process.
11503724 - Medical device; exemption from premarket notification; class ii devices; barium enema r...
18977384 - Withdrawn: book review: biofilms in the food environment, h.p. blaschek, h.h. wang, m.e...
19824584 - Changing winds: practice implications of acetaminophen regulations.
21527294 - Social modeling of food purchases at supermarkets in teenage girls.
2919184 - Hippocampal specialization of food-storing birds.
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  IEEE engineering in medicine and biology magazine : the quarterly magazine of the Engineering in Medicine & Biology Society     Volume:  7     ISSN:  0739-5175     ISO Abbreviation:  IEEE Eng Med Biol Mag     Publication Date:  1988  
Date Detail:
Created Date:  2008-02-04     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8305985     Medline TA:  IEEE Eng Med Biol Mag     Country:  United States    
Other Details:
Languages:  eng     Pagination:  90-1     Citation Subset:  -    
Affiliation:
Food and Drug Adm., Silver Spring, MD.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


Previous Document:  FDA regulation of new devices-expedited review.
Next Document:  Ventricular assist systems for temporary life support: device readiness testing.