During this holiday season, when presents are being packaged and shipped at high volumes, I thought it would be appropriate to talk about the importance of labeling.

Prior to my start at RQS I had not realized how heavily involved Regulatory Affairs was in labeling decisions. I guess I had not thought about labeling at all because for me, labeling and instructions were just something that was always there, they somehow (in some magical way) always appeared (either on the device or with the device). However since working with a number of clients, I have realized that labeling is an important aspect of the device that Regulatory Affairs gives feedback on. Depending on the size of the company there can be technical writers who actually create and design the labels or Regulatory Affairs can be the ones who are in charge of creating the labels.

Medical device labeling includes outside package labeling, labeling on the actual device, warning/caution labeling as well as user/provider manuals and instructions for use. While the outside package labeling can be a simple 6" by 4" label, the user manuals can be hundreds of pages with detailed instructions on how to properly use the device. Regulatory Affairs has to review and approve all of this content. Regulatory Affairs has to understand the various labeling regulations in each country to decide what is acceptable to put on the label and whether or not country specific labels need to be created.

One thing I have recently been working on which I find to be very interesting is creating a user insert guide. The insert is a single page instruction sheet for the home user of a device. This is created to provide quick and easy clarity to the patient/user in an understandable way. The interesting part about this insert is the fact that it is going to be used internationally and the client I am working with is trying to find a way to have the insert contain only pictures. The reason for this is because if the insert only contains pictures, they will not have to pay a large amount of money to get the insert translated to various languages in which the device is sold. This makes creating the insert slightly more challenging because the pictures have to be descriptive and clear.

Labeling is extremely important in the medical device industry because it provides information like the expiration date, CE mark, numbers of times of use as well as instructions for use. Understanding the labeling of the device is really important for both the physician and the patient. Regulatory Affairs has to be able to manage this content so that the safety of the patient is intact.

--Jillian F. Walker

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