Question

MDUFMA authorized 3rd party establishment inspections under carefully prescribed conditions. All the following prescribed conditions about 3rd party establishment inspections are true EXCEPT:

A. The establishment must market at least one device in the US and must market a device
"in one or more foreign countries."
B. Manufactures of class III devices are not eligible for 3rd party inspections.
C. In order to be eligible, an establishment's most recent inspection must be NAI or VAI.
D. Establishments are required to notify FDA of the person it intends to use and FDA
must agree to the selection.

Answer 1

The correct answer is B. Manufactures of class III devices are not eligible for 3rd party inspections.

Step-by-step explanation:

The correct answer is B. Manufactures of class III devices are not eligible for 3rd party inspections.

The MDUFMA (Medical Device User Fee and Modernization Act) authorized 3rd party establishment inspections under carefully prescribed conditions. These conditions include:

1. The establishment must market at least one device in the US and must market a device "in one or more foreign countries."
2. In order to be eligible, an establishment's most recent inspection must be NAI (No Action Indicated) or VAI (Voluntary Action Indicated).
3. Establishments are required to notify FDA of the person it intends to use, and FDA must agree to the selection.

However, manufactures of class III devices are not eligible for 3rd party inspections.