Quick & Easy Guide to Medical Device Labeling RequirementsRoyal Label
Medical device labeling is an essential part of the manufacturing process for every medical device produced in the United States. In 2016, the Food and Drug Administration (FDA) released a new ruling that expanded on medical device manufacturer’s options for using medical device symbols to present required information on their product labels. Many things have changed in the four years since this ruling. It is essential for all medical device manufacturers to understand the regulations that now apply to labeling medical devices.
Modern manufacturers must understand these recent changes to requirements to prevent patient harm and expensive regulatory violations. Royal Label is an expert label printing company in Boston that provides product label printing for highly specialized industries such as medical device manufacturing. As a result, we can be your primary partner to help you stay up to date with new medical label requirements.
If you need to revamp your medical equipment labels to meet the recently implemented FDA regulations, it’s essential to work with a professional label printing company like us. We can work closely with your team to determine your regulatory obligations and better understand the newly implemented label requirements. Our professional label printing services will ensure your devices meet all applicable regulations so you can continue serving your customers.
What is the Definition of a Medical Device?
If your company produces any type of medical equipment, it’s vital to understand a medical device’s legal definition. The FDA’s official definition of a medical device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or another similar or related article, including a part or accessory” that exists for the “cure, mitigation, treatment, or prevention of disease.” If a product falls under this legal designation, you must follow all applicable medical device regulations regarding your products’ production, packaging, and labeling.
Once you have confirmed that the product you manufacture qualifies as a medical device under this definition, you must then determine whether your organization is responsible for meeting medical label requirements for your devices. Responsibility for this consideration may fall to one or more parties involved in the supply chain of your products.
New FDA Medical Device Label Printing Rules
As of 2016, the FDA now requires the use of the Unique Device Identification (UDI) system. This system provides a unique label for every version of a manufactured medical device to enable traceability in manufacturing. Every UDI label includes a device identifier that allows tracking all items using the Global Unique Device Identification Database (GUDID).
The FDA requires a UDI label to include a readable portion with a plain-text UDI code as well as a machine-readable barcode. Issuing agencies accredited by the FDA assume responsibility for giving unique identifiers as new products enter production. New regulations for UDI labels first applied to lifesaving, implantable, and life-sustaining medical devices and eventually expanded on September 24, 2020, to include all medical devices.
UDI labels include the plain-text and machine-readable product codes and the item’s brand name, a complete description of the product, product size, the manufacturer’s catalog number for the product, the expiration date (if applicable), full handling instructions, and more. These are reasons proper printing of an effective UDI label is vital to medical device production.
How to Meet FDA Medical Label Requirements
The new medical device regulations imposed by the FDA aim to increase medical device traceability and keep manufacturers accountable for the products they create for the healthcare industry. If your operation needs to ensure complete FDA regulatory compliance, it is vital to work with an experienced professional label printing company with the capability to create the labels your devices require.
UDI labels typically include FDA-approved medical device symbols that streamline a label’s appearance while ensuring compliance with the new UDI system for medical device label printing. Additionally, your medical devices may require you to provide Instructions for Use (IFU), meaning your professional labeling company must have carefully printed IFUs for your devices.
Choose Royal Label for Medical Device Label Printing Compliance
Royal Label is an expert label printing company in Boston with the experience necessary to handle complex medical device regulations. Our digital label printing services allow our customers to have complete control over the label design process and tailor printing runs to their unique needs. We can ensure that your operation meets FDA-mandated requirements and will work with the other companies involved in your medical device supply chains for a more streamlined labeling process.
Royal Label guarantees your products will meet all medical label requirements the first time, every time. Contact us today for more information about our professional label printing services!