Regulatory Affairs Certification (RAC) Practice Exam

Under what circumstances can the FDA require a postmarketing study after product approval?

1. When the product is a Class I device

2. Approval granted via accelerated provisions or deferred pediatric studies

3. If the product has not been adequately tested

4. For all approved products regardless of risks

The correct answer is: Approval granted via accelerated provisions or deferred pediatric studies

The FDA can require a postmarketing study after product approval particularly in cases where the approval was granted through accelerated provisions or when there are deferred pediatric studies. This is because the accelerated approval pathway is designed for products that fill an unmet medical need, and the approval is based on preliminary evidence of benefit. To confirm and further evaluate the product's efficacy and safety, the FDA often mandates that additional studies be conducted post-approval. This requirement reflects the need to gather more comprehensive data, especially in populations that were not fully studied during the initial trials, such as children in the case of deferred pediatric studies. These additional studies help ensure that once a product is available to the public, its performance and safety can be closely monitored and updated as more information is obtained. In contrast, a Class I device typically requires less regulatory scrutiny and does not usually necessitate postmarketing studies unless specific safety concerns arise. Similarly, while inadequate testing may raise concerns, it does not automatically lead to a requirement for a postmarketing study under FDA regulations unless it pertains to one of the specific cases that involve high risks or special pathways of approval. The FDA does not mandate postmarketing studies for all approved products, as this would be unnecessary for many low-risk items.