Medical Device Amendments of 1976

E165702

United States federal law medical device regulation

The Medical Device Amendments of 1976 are U.S. legislation that established a comprehensive regulatory framework for the safety and effectiveness of medical devices, including classification, premarket approval, and performance standards.

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All labels observed (1)

Label	Occurrences
Medical Device Amendments of 1976 canonical	2

Statements (48)

Predicate	Object
instanceOf	United States federal law ⓘ medical device regulation ⓘ
amends	Federal Food, Drug, and Cosmetic Act ⓘ surface form: Federal Food Drug and Cosmetic Act Federal Food, Drug, and Cosmetic Act ⓘ surface form: Food Drug and Cosmetic Act of 1938
appliesTo	manufacturers of medical devices sold in interstate commerce in the United States ⓘ
authorizes	banning of dangerous devices ⓘ device recalls ⓘ inspection of device manufacturing facilities ⓘ
ClassIDescription	devices subject to general controls ⓘ
classificationCriterion	intended use of device ⓘ level of control necessary to assure safety and effectiveness ⓘ
ClassIIDescription	devices subject to general and special controls ⓘ
ClassIIIDescription	devices requiring premarket approval ⓘ
codifiedIn	21 U.S.C. § 360c et seq. ⓘ
country	United States of America ⓘ surface form: United States
creates	risk-based classification of devices ⓘ
dateEnacted	1976-05-28 ⓘ
enactedBy	United States Congress ⓘ
establishes	510(k) premarket notification ⓘ Class I medical devices ⓘ Class II medical devices ⓘ Class III medical devices ⓘ adverse event reporting requirements for devices ⓘ good manufacturing practice requirements for devices ⓘ medical device classification system ⓘ performance standards for medical devices ⓘ postmarket surveillance authorities ⓘ premarket approval requirement for certain devices ⓘ premarket notification process ⓘ
field	health law ⓘ medical device law ⓘ
historicalContext	enacted after concerns about safety of implanted and complex devices ⓘ
jurisdiction	United States government ⓘ surface form: United States federal government
purpose	to ensure safety and effectiveness of medical devices ⓘ to provide reasonable assurance of safety and effectiveness ⓘ
regulates	medical devices ⓘ
regulatoryAgency	Food and Drug Administration ⓘ
regulatoryCenter	Center for Devices and Radiological Health ⓘ
relatedTo	Federal Food, Drug, and Cosmetic Act ⓘ surface form: Federal Food Drug and Cosmetic Act Food and Drug Administration ⓘ
requires	adequate labeling for medical devices ⓘ device listing ⓘ premarket approval for high risk devices ⓘ registration of device manufacturers ⓘ
shortEffect	created modern U.S. medical device regulatory framework ⓘ
signedBy	Gerald Ford ⓘ
signingPresident	Gerald Ford ⓘ
yearEnacted	1976 ⓘ

Referenced by (2)

Full triples — surface form annotated when it differs from this entity's canonical label.

Federal Food, Drug, and Cosmetic Act → amendedBy → Medical Device Amendments of 1976 ⓘ

FDC Act → amendedBy → Medical Device Amendments of 1976 ⓘ