Medical Device Amendments of 1976
E165702
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.
All labels observed (1)
| Label | Occurrences |
|---|---|
| Medical Device Amendments of 1976 canonical | 2 |
How this entity was disambiguated
This entity first appeared as the object of triple T1445196 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: Medical Device Amendments of 1976 Context triple: [Federal Food, Drug, and Cosmetic Act, amendedBy, Medical Device Amendments of 1976]
-
A.
False Claims Amendments Act of 1986
The False Claims Amendments Act of 1986 is a major U.S. federal law that strengthened the government’s ability to combat fraud against federal programs by expanding whistleblower (qui tam) provisions and increasing penalties for false claims.
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B.
Stevenson-Wydler Technology Innovation Act of 1980
The Stevenson-Wydler Technology Innovation Act of 1980 is a U.S. federal law designed to promote the transfer of technology from federal laboratories to the private sector and encourage innovation and commercialization of federally funded research.
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C.
National Cancer Act of 1971
The National Cancer Act of 1971 is a landmark U.S. law that greatly expanded federal funding and coordination for cancer research, prevention, and treatment, helping launch the modern "war on cancer."
-
D.
Federal Technology Transfer Act of 1986
The Federal Technology Transfer Act of 1986 is a U.S. law that strengthened and formalized the process for federal laboratories to collaborate with industry and transfer government-developed technologies into the private sector.
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E.
Bayh–Dole Act
The Bayh–Dole Act is a landmark 1980 U.S. law that allows universities, small businesses, and other institutions to retain ownership of inventions developed with federal funding, spurring technology transfer and commercialization.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
NED2
Entity disambiguation (via description)
gpt-5-mini-2025-08-07
Target entity: Medical Device Amendments of 1976 Target entity description: 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.
-
A.
False Claims Amendments Act of 1986
The False Claims Amendments Act of 1986 is a major U.S. federal law that strengthened the government’s ability to combat fraud against federal programs by expanding whistleblower (qui tam) provisions and increasing penalties for false claims.
-
B.
Stevenson-Wydler Technology Innovation Act of 1980
The Stevenson-Wydler Technology Innovation Act of 1980 is a U.S. federal law designed to promote the transfer of technology from federal laboratories to the private sector and encourage innovation and commercialization of federally funded research.
-
C.
National Cancer Act of 1971
The National Cancer Act of 1971 is a landmark U.S. law that greatly expanded federal funding and coordination for cancer research, prevention, and treatment, helping launch the modern "war on cancer."
-
D.
Federal Technology Transfer Act of 1986
The Federal Technology Transfer Act of 1986 is a U.S. law that strengthened and formalized the process for federal laboratories to collaborate with industry and transfer government-developed technologies into the private sector.
-
E.
Bayh–Dole Act
The Bayh–Dole Act is a landmark 1980 U.S. law that allows universities, small businesses, and other institutions to retain ownership of inventions developed with federal funding, spurring technology transfer and commercialization.
- F. None of above. chosen
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 ⓘ |
How these facts were elicited
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: Medical Device Amendments of 1976 Description of subject: 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.
Referenced by (2)
Full triples — surface form annotated when it differs from this entity's canonical label.