Question

The originator of the Category 1 deficiency report must forward the report to the designated screening point within what time frame after the discovery of the deficiency?

Answer 1

The originator of the Category 1 deficiency report must forward the report to the designated screening point within 15 days after the discovery of the deficiency.

Step-by-step explanation:

The originator of the Category 1 deficiency report must forward the report to the designated screening point within 15 days after the discovery of the deficiency.

This is similar to how the sponsor of a drug must report unexpected serious and fatal adverse drug events to the FDA within 15 days. Other events can be reported on a quarterly basis.

The FDA also receives voluntary adverse drug event reports through its MedWatch program.