Regulatory Affairs Certification (RAC) Practice Exam

When should the manufacturer of a Class III medical device expect to have an FDA establishment registration inspection?

1. During the product development phase.

2. Prior to approval of the PMA.

3. After the product has been launched.

4. At any time during the review of the application.

The correct answer is: Prior to approval of the PMA.

The manufacturer of a Class III medical device should expect to have an FDA establishment registration inspection prior to the approval of the PMA (Pre-Market Approval). This is because the FDA conducts inspections to ensure that the manufacturing practices comply with the Quality System Regulation (QSR) before they grant marketing approval. The inspection is critical as it assesses whether the manufacturer adheres to the necessary regulations regarding quality, safety, and efficacy, which are essential for Class III devices that pose the highest risk. Such oversight is part of the pre-approval process, helping to confirm that the device can be reliably manufactured in a manner that meets regulatory standards. This ensures that the device is not only effective but also safe for patients once it reaches the market, promoting a thorough review of the manufacturing processes before any commercial distribution occurs.