medical device label

Introduction

The U.S. client is the manufacturer of IVDs and blood products. The client had created labeling in compliance with the US FDA labeling regulations for a new product.

Business Challenge

The internal team at the company had conflicting views on whether or not the labeling documents, consisting of almost 60 images complied with the latest FDA’s labeling requirements. The team had spent months discussing the matter internally with no consensus.

Solution


The Senior Director of Regulatory Affairs wanted to obtain clarity on the labeling before the FDA submission. RegDesk compiled a flash team of three experienced FDA labeling experts to review the labeling. These experts on average had 20 years of regulatory experience specifically with IVD products. The experts provided feedback and identified claims that would raise questions with the FDA.

Results


The Senior Director obtained multiple viewpoints on the labeling within 3 weeks. The internal review process of the labeling was a vain attempt and had wasted several months. The client leveraged the insights received through RegDesk to modify the claims appropriately and forecast FDA’s response.


Want to know more about our solutions? Speak to a RegDesk Expert today!