Question

Pre-market Notification Requirements would apply to a device that is:

A) Substantially equivalent to a pre-amendment device
B) Intended solely for use by a specific physician
C) Not equivalent to currently marketed devices
D) Intended for veterinary use

Answer 1

Pre-market Notification Requirements, or 510(k) clearance, is necessary for a medical device that is 'Substantially equivalent to a pre-amendment device' and allows it to be legally marketed in the United States.

Step-by-step explanation:

Pre-market Notification Requirements, also known as 510(k) clearance, would apply to a device that is: A) Substantially equivalent to a pre-amendment device. This process allows a new medical device to be legally marketed in the U.S. if it can be demonstrated that the device is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to premarket approval. Hence, devices intended solely for use by a specific physician, those that are not equivalent to currently marketed devices, or intended for veterinary use would not be subject to these pre-market notification requirements unless they too can be shown to be substantially equivalent to a pre-existing device on the market.