There are strict FDA best practices for medical device patient labels. Let’s look at why patient labeling is essential, when it’s necessary, and FDA indications and usage guidelines.
Medical device labeling is a critical FDA best practice that ensures patients use the device safely and effectively, providing users with vital device information about proper uses, risks, and benefits.
Medical device labeling should convey information in simple language so that patients or caregivers can understand how to operate and maintain the device, how it interacts with the body to accomplish its intended purpose and provide a clear understanding of safety and disposal issues.
Patient labeling for medical devices isn’t always required, but it’s an FDA best practice to supply information about a device to the user or caregiver if the label increases their knowledge of the device. An informative label increases the likelihood of the patient using the device as intended by the manufacturer.
To determine if a patient label is necessary for your medical device, ask yourself:
- Does the audience need or want specific information about the device?
- Is there anything unique about the device that should be explained to the patient?
- Does the audience already know this information?
Medical device patient labeling isn’t usually necessary if the patient doesn’t benefit from knowing the information. For example, if a medical device is a tool used by the healthcare professional, and the patient isn’t involved in device selection, a patient label isn’t typically required.
As an experienced manufacturer of record for medical devices, we hold ourselves accountable for every step of the manufacturing process, from prototyping to final assembly.
Patient labels include FDA indications and usage guidelines. If you’re considering developing a patient label for your new medical device, documentation should be submitted to the FDA during your regulatory journey. If you’re using a contract manufacturer, the company designing and producing the device can help you create the proper documentation for your device’s guidelines.
Along with device risks and benefits, the following usage guidelines are typically included on patient labels for medical devices:
FDA indication for use includes a general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, as well as the patient population intended for the device’s use. Indication for use documentation should address who will be using your device and why they should use it. FDA indications for use don’t typically change your regulatory path, but ensuring the indication for use information is accurate and clear helps streamline your device’s time-to-market process.
Intended use information includes guidelines for what your device is meant to do. The label’s intended use information impacts your device’s classification and regulatory path, so it’s important to be accurate and precise when creating intended use documentation.
Contraindications on your device’s patient label should include conditions when the device shouldn’t be used because the risk outweighs the benefit. For example, if a particular group of patients shouldn’t use your device due to their health status, it should be included in your label’s contraindication section. Contraindications to the use of a device can include patients of a certain age, gender, disease state, or health status at risk of being harmed if they use the device.
A medical device’s instructions for use (IFU) are detailed, action-oriented instructions on how to use the product provided in a patient-friendly manner. The FDA has strict guidelines for preparing IFUs because every product you manufacture is required to include one. When preparing an IFU for your device, ensure you include step-by-step instructions that are clear and accurate.
A Medical Device Manufacturer That Knows FDA Best Practices for Patient Labels
Remington Medical has manufactured a line of medical devices, and we’re also a contract manufacturer specializing in designing and developing high-quality, disposable medical devices for a variety of specialty fields. Our extensive experience includes developing our own medical device patient labels and helping our customers create detailed, accurate documentation for the FDA based on their unique product guidelines. Contact us today to learn more about our contract manufacturing services for medical devices.
- Navigating the Validation Challenges in Multi-Function Medical Devices February 7, 2024
- Managing Changes to Medical Device Packaging February 7, 2024
- What Is Contract Manufacturing for Medical Devices? January 25, 2024