Question

The manufacturer of an approved prostate-specific antigen (PSA) test developed a new automated analyzer to perform the total PSA testing. There was no change to the test's indications for use or technology and no new clinical data were required. Only analytical testing was performed to demonstrate that the new analyzer did not alter the performance of the assay. What kind of PMA supplement to the approved PMA will be required for this change?

A) Special PMA Supplements Changes Being Affected
B) 30 day Notice
C) Real Time Supplement
D) 180-Day Supplement

Answer 1

For a change in the PSA testing equipment that requires no new clinical data and doesn't alter the assay's indications or technology, a 30 day Notice PMA supplement is required.

Step-by-step explanation:

The type of PMA supplement required for a change in the total PSA testing equipment, when no new clinical data is needed and there are no changes to the test's indications for use or technology, is known as a 30 day Notice.

This type of supplement is typically utilized when a manufacturer intends to make a change to a device that has received premarket approval (PMA), as long as the change does not affect the safety or effectiveness of the device. This particular scenario describes a situation where only analytical testing is needed to demonstrate that the new analyzer has the same performance as the original assay, indicating that the change is unlikely to impact the device's safety or effectiveness significantly.