Question

Which approval process is likely to be required for a new heart rate monitor which is substantially similar to a previously approved device? Select one: a. 510K b. PMA c. Clinical trials d. Exempt status

Answer 1

Answer:

A

Explanation:

510K approval is required to demonstrate that device to be marketed is substanitally similar to an already legally approved and marketed device and therefore safe to use

PMA approval is required to approve Class III type medical devices that are new and have not been marketed. They involve human participants.

Clinical trials involve volunteers and is carried out when a drug or device has been tested in laboratory

Exempt status is given to class I devices and not to class III devices.

Answer 2

Answer:

a. 510K

Explanation:

510K is a process carried out by the US government, whenever it is necessary to approve a medical device, where it will not be necessary a series of clinical trials to establish whether the device is safe and whether it really improves an individual's health, that is, this device needs little or no supervision so that it receives government approval and can be marketed.

An example of this can be seen in the question above, where the 510K will allow the approval of a new heart rate monitor substantially similar to a previously approved device. Since this previously approved device has already received all the necessary assessments, the new device does not need to go through all the assessments.