Question

A medical device is refused entry to the US. All of the following may be reasons for refusal EXCEPT for the lack of:

A. Establishment registration by the foreign manufacturer
B. Medical device listing by the foreign manufacturer
C. Substantially equivalent letter from FDA
D. Establishment registration by the initial distributor

Answer 1

The lack of establishment registration by the initial distributor is not a valid reason for refusal of a medical device entry into the US.

Step-by-step explanation:

The correct answer is D. Establishment registration by the initial distributor. Lack of establishment registration by the foreign manufacturer, medical device listing by the foreign manufacturer, and substantially equivalent letter from FDA can all be reasons for refusal of a medical device entry into the US. However, the lack of establishment registration by the initial distributor is not a valid reason for refusal.