Question

How to remember FDA drug and device recall classifications

Answer 1

FDA drug recall classifications include Class I for serious adverse consequences or death, Class II for temporary or reversible consequences, and Class III for products unlikely to cause adverse consequences.

Step-by-step explanation:

To remember the FDA drug and device recall classifications, it's important to understand the implications and severity associated with each class. Recall classifications fall into three main categories:

1. Class I: This recall involves situations where there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
2. Class II: This recall is initiated when a product may cause temporary or medically reversible adverse health consequences, but where the probability of serious adverse health consequences is remote.
3. Class III: This recall is initiated when a product is not likely to cause adverse health consequences.

Memorization can be aided by associating Class I with immediate and severe risk, Class II with less immediate and reversible risk, and Class III with minimal risk. Creating acronyms or using mnemonic devices can also help in retaining this information.