Ace the 2025 RAC Exam – Unleash Your Regulatory Expertise Today!

Question: 1 / 400

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

During the product development phase.

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.

Get further explanation with Examzify DeepDiveBeta

After the product has been launched.

At any time during the review of the application.

Next Question

Report this question

Download Regulatory Affairs Certification (RAC) Practice Exam PDF Study Guide
Subscribe

Get the latest from Examzify

You can unsubscribe at any time. Read our privacy policy