Question

u.s. food and drug administration
guidance to health hazard evaluation committee
the food and drug administrations recall regulation requires the conduct of an evaluation of the health
hazard (actual or potential) presented by a product being recalled or considered for recall. the regulations
specify the factors to be considered, among others, by the health hazard evaluation committee in
making the health hazard evaluation.

1. the population at risk
2. conditions that may exacerbate or attenuate the risk of its occurrence
3. the risk associated with the product under conditions of use (as labeled)
4. the likelihood of the risk occurring in the future

the purpose of these guidelines is:

• to assist the committee in the identification and documentation of the various factors listed in 21

cfr 7.41(a) that are to be considered in making the health hazard evaluation.

• to determine what additional data and information should be collected and evaluated during the

recall either to confirm or revise the health hazard evaluation.
the questions listed below are not all inclusive nor are they relevant to all recall situations. they are
intended to focus attention on factors related to the significance of health hazards likely to be associated
with a product being recalled or considered for recall.
21 cfr 7.41(a)(1). whether any adverse reactions have already occurred from the use of the product.

1. what is the name of the product (trade and generic)? what are its indications for use, where

applicable?

1. what adverse reactions have already occurred in association with use of the product?
2. what documentation is there to support the association of adverse reactions with the use of the

product?

1. was the product used in conformance with its labeled directions for use? (the health hazard

you work for a drug manufacturer. based on the
document shown, the main reason for a health
hazard evaluation is to:
a. identify the population at risk.
b. determine the future risk.
c. identify the products use.
d. review the products label.
e. assess the overall risk.

Explanation:

The guidelines in 21 CFR 7.41(a) aim to assist in evaluating the overall risk of a product. This involves considering various factors such as the population at risk, conditions that may affect risk, associated risks, and future likelihood of risk. The ultimate goal is to assess the overall risk to determine if a recall is necessary.

Answer:

E. assess the overall risk.