Medical devices come with a lot of regulations, and one of the main requirements is to be labeled. To help you, here are the requirements for medical device labeling.
- 1 Labeling Must Be In English
- 2 Must Be Clear And Conspicuous
- 3 Must Be Legible
- 4 The Name Of The Manufacturer
- 5 Contact Information
- 6 Must Include a “Business” Address
- 7 The Expiration Date
- 8 Requirements For Certain Colored Packaging
- 9 Must Be Tamper Evident
- 10 Labeling Exemption For Some Devices
Labeling Must Be In English
With a few exceptions, labeling for medical devices must be in English. Only small medical devices such as blood glucose meters and drug infusion pumps can be labeled in English or Spanish except for the brand name.
Must Be Clear And Conspicuous
Clarity is an inevitable part of medical device labeling. According to Seagull Scientific, “medical device labeling must be in a print size that is easy to read so that it is clear and conspicuous.”
Must Be Legible
Medical devices are packaged, so they don’t become damaged when in transit or when in storage before use by a patient or a doctor. It is important for the labeling to be still legible even after the device is packaged.
The Name Of The Manufacturer
This will help ensure that any issues with a product can be traced back to the manufacturer and will allow people who might have problems with a medical device to identify who manufactured it and where to contact them for information and assistance.
This contact information (address, phone number, and email) must be on the label in addition to the name of the manufacturer.
Must Include a “Business” Address
Once again, the business address will help provide an avenue for contacting the manufacturer when needed for information or repairs.
The Expiration Date
Mentioning the expiration date is important in medical device labeling. An example would be medicine with an expiration date because it loses effectiveness over time or could go bad if not used by that date.
Requirements For Certain Colored Packaging
Any medical device that is orange or yellow must have a label stating that it is a “safety-related” device.
Must Be Tamper Evident
The labeling must be designed so that it is obvious if someone has opened the package to take the medical device out or to try to take an unauthorized look at the product or its labeling. It will help prevent tampering with the product and alert users if someone has tried to do so.
Labeling Exemption For Some Devices
There are labeling exemptions for some products that suggest they are a self-limiting treatment, a “treatment” for a specific use, and any device that has no “effect” on the person’s health. These rules will be the subject of many questions during the rulemaking process.
Labeling Exemption For Small Medical Devices
The exemption applies to medical devices that weigh 4 ounces or less or measure six cubic centimeters or less.
Labeling Exemption For Individual Biological Products
Biological products such as vaccines and antibodies will not need to have labels that identify the manufacturer, though they will still need to list all of the necessary information in text and graphics in a format that is easy for consumers to read and understand to ensure the device provides the proper protection from diseases and harmful substances when used as directed under label instructions.
Labeling Exemption For Certain Devices
There is no labeling requirement for any device used to treat, diagnose, or cure a person’s allergies or other conditions if the device is designed so that it can’t affect the person’s health. The same exemption applies to topical products applied directly to a person’s skin, devices designed to hold food, medications, other substances in the body, diagnostic tools used by doctors and other healthcare providers, and orthotic devices.
It is important to know that medical device labeling is not fun to do, and it’s not easy to understand either. It can be not very clear, but it is essential for your safety and your treatment. This information will allow you to make informed decisions about the medical devices you are using and choosing, which will ensure you get the best care possible.