Document Detail


Medical devices; exemption from premarket notification and reserved devices; Class I--FDA. Proposed rule.
MedLine Citation:
PMID:  10187398     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The Food and Drug Administration (FDA) is proposing to amend its classification regulations to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate those class I devices that remain subject to premarket notification requirements under the new statutory criteria for premarket notification requirements. The devices FDA is proposing to designate as exempt do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA.
Authors:
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  63     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  1998 Nov 
Date Detail:
Created Date:  1999-01-12     Completed Date:  1999-01-12     Revised Date:  2000-12-18    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  63222-53     Citation Subset:  H    
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MeSH Terms
Descriptor/Qualifier:
Anesthesiology / instrumentation
Chemistry, Clinical / instrumentation
Dental Instruments / standards
Device Approval / legislation & jurisprudence*
Equipment and Supplies / adverse effects,  classification*,  standards
Hematology / instrumentation
Immunologic Techniques / instrumentation
Microbiological Techniques / instrumentation
Pathology / instrumentation
United States
United States Food and Drug Administration

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


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