The Importance of Packaging & Labeling Regulations

by | Oct 22, 2020 | FDA, Medical Devices, Quality, Regulatory

Few people outside of the industry know how big of a role the FDA has in product labeling and packaging. Every product approved by the FDA has very specific guidelines for its packaging and labeling, and these guidelines are often changing to meet new challenges that arise. Over time, due to the increasing complexity of the medical world, drug labels and packaging have had to become more and more complex. Typically, the reason for changing packaging regulations is adverse events. When an abundance of similar adverse events starts to be reported, the FDA will start working to determine how the regulations around packaging and labeling can be changed to make the product details clearer for the user. Creating guidelines for drug packaging and labeling is a balancing act between making sure that all of the information is present, but also that all of the information in arranged/formatted to ensure that the user will read the most important information.

In the past year, the FDA has been working on changing regulations related to insulin pens, their packaging, and how they are distributed to the people using them. Historically, insulin pens have been sold in cartons containing 2-5 pens. The cartons follow all FDA regulations for labeling, but the pens themselves do not due to lack of feasibility. This creates a problem because people will often throw away the cartons before using all the included pens. There are also times when a health care provider will have a medical reason to dispense a single pen to a patient, in which case the patient never has the information from the carton in the first place. This leaves the patient in a situation where they may have multiple pens of varying insulin types and doses, without any information about which one is which. In turn, this creates the possibility for people to over or under dose themselves, mistakenly skip doses, or operate the pen without clear and proper instruction.1

This situation presents a unique challenge because it is not feasible to put all the labeling information onto the insulin pen itself. Therefore, it is necessary to rely on the carton for the product information. Because of this, the FDA is working on making a regulation such that all insulin pens will be in individual cartons, rather than the usual 2-5. This way, a patient would never be put in a situation with a pen but no carton.

To conclude, getting packaging and labeling FDA approved is a significant part of any product on its way to the market. If you need guidance on any packaging or labeling for your product, our regulatory experts at EMMA International can help ensure your product is compliant with the regulatory requirements. Contact us at 248-987-4497 or info@emmainternational.com for additional information.


1FDA (October 13, 2020). Drug Safety and Availability. Retrieved on October 21st, 2020 from https://www.fda.gov/drugs/drug-safety-and-availability/fda-advises-health-care-professionals-and-patients-about-insulin-pen-packaging-and-dispensing

Catherine Milford

Catherine Milford

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

Ready to learn more about working with us?

Pin It on Pinterest

Share This