Medical Device Amendments of 1976

GPTKB entity

Statements (20)
Predicate Object
gptkbp:instanceOf gptkb:United_States_federal_law
gptkbp:amendedBy gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
gptkbp:category health law
gptkbp:country gptkb:United_States
gptkbp:dateEnacted May 28, 1976
gptkbp:enactedBy gptkb:United_States_Congress
gptkbp:enforcedBy gptkb:U.S._Food_and_Drug_Administration
gptkbp:establishes recordkeeping and reporting requirements for medical devices
good manufacturing practices for medical devices
medical device classification system
performance standards for medical devices
premarket approval process for medical devices
https://www.w3.org/2000/01/rdf-schema#label Medical Device Amendments of 1976
gptkbp:publicLawNumber gptkb:Public_Law_94-295
gptkbp:purpose to ensure safety and effectiveness of medical devices
gptkbp:regulates medical devices
gptkbp:signedBy gptkb:President_Gerald_Ford
gptkbp:sponsor gptkb:Senator_Edward_Kennedy
gptkbp:bfsParent gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
gptkbp:bfsLayer 6