Final answer:
The Medical Device Amendment of 1976 instituted Medical Device Regulations under the FDA and led to the creation of the CDRH, expanding safety and regulation measures for medical and certain non-medical devices. c) The Medical Device Regulations
Step-by-step explanation:
The Medical Device Amendment of 1976 established the Medical Device Regulations which is the correct answer to the question posed. This amendment authorized the Food and Drug Administration (FDA) to regulate medical devices to ensure their safety and effectiveness.
The amendment also led to the creation of the Center for Devices and Radiological Health (CDRH), which is the branch of the FDA responsible for the premarket approval of all medical devices. Devices regulated by the CDRH range from everyday items like toothbrushes to complex implantable devices such as brain pacemakers. This amendment expanded the original authority for government regulation of biological products set forth by the 1902 Biologics Control Act and the 1944 Public Health Service Act. The CDRH also regulates non-medical devices that emit certain types of electromagnetic radiation, such as cellular phones and microwave ovens.