Respuesta :
FDA governmental agency has authority as outlined in the safe medical device act.
The Center for Devices and Radiological Health of the FDA is in charge of overseeing businesses that produce, repackage, relabel, and/or import medical devices that are sold in the US.
Additionally, CDRH oversees the regulation of both medical and non-medical radiation-emitting electronic products, including lasers, x-ray machines, ultrasound devices, microwave ovens, and color televisions.
There are three classes of medical devices: I, II, and III. From Class I to Class III, regulatory oversight is more stringent.
The regulatory specifications for a generic device type are specified in the device categorization regulation.
Premarket Notification is not required for the majority of Class I devices, Class II devices must submit a 510(k), and Class III devices must receive premarket approval.
"Classification of Medical Devices" provides information about device classification as well as a link to the Product Classification Database.
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