One of the most frequent questions we get at Sterling is, “what does it mean for the U.S. Food and Drug Administration (FDA) to classify a medical device?” especially when it comes to digital wellness products. Advancements in digital technologies open a world of opportunities in the digital health and wellness space, for medical device companies as well as wellness companies whose products are mostly not regulated by the FDA. However, there is confusion for companies designing consumer products over whether their product must go through the FDA regulatory process.
The FDA defines a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article (…) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease (…) intended to affect the structure or any function of the body.”
To answer the question about how classification is determined, the agency looks at two major factors:
Intended Use and Indications for Use
“Intended use” and “indications for use” are deciding factors in determining whether consumer digital products are medical devices. Title 21 of the Code of Federal Regulations defines “Indication for use” as the disease or condition the device will diagnose, treat, prevent, cure, or mitigate. The regulation includes a description of the patient population for which the device is intended. Intended Use is defined as the general purpose of the device or its function and encompasses the indication for use.
Medical Device Class
Classification depends on the intended use, indications for use, and risk the device poses to the patient and/or the user. There are big differences between Class I and Class II medical devices as well as Class III devices. As the device class increases, regulatory controls also increase, with Class I devices subject to the least regulatory control, and Class III devices subject to the most stringent. Title 21 of the Code of Federal Regulations requires Regulatory controls for all device classifications defined, including:
Class I:
In establishing what it means for the FDA to classify a medical device, the biggest factor is risk. Class I devices carry a low risk to patients and/or users. These devices are subject to the fewest regulatory controls, but still must adhere to the FDA’s general controls, which include provisions of the federal Food, Drug, and Cosmetic Act on adulteration, misbranding, device registration and listing, records and reports, banned devices, and notification and repair, replacement, or refund. Some Class I devices are also subject to premarket notification (510(k)) or De Novo. This occurs in the event there is no legally marketed predicate device. They are also subject to good manufacturing practices (GMP).
Class II:
A Class II medical device poses a medium or intermediate risk to patients and/or users, so general controls are not enough to ensure safety and effectiveness of the product. Class II medical device requirements necessitate meeting special controls in addition to general controls, including performance standards, post-market surveillance, patient registries, and guidances and guidelines as well as other appropriate actions. Most FDA Class II medical devices must undergo a 510(k) clearance, demonstrating that their device is Substantially Equivalent (SE) to one or more predicate devices already cleared by the FDA. An FDA Class II medical device is more likely to come in contact with a patient as compared to a Class I device.
Class III:
When determining a Class III device, the FDA classifies the device as the highest risk to patients and/or users. These devices support or sustain human life, are substantially important in preventing impairment of human health, and present a potential unreasonable risk of illness or injury. Class III devices must follow the most rigorous controls in the product lifecycle. Most require a Premarket Approval (PMA) application usually involving clinical trials and data collection.
Conclusion
At Vantage, our FDA regulatory consultants can help you understand FDA classification. We can help whether you are working on a digital health product or other device. We will also help you determine your regulatory pathway and achieve regulatory, quality, and clinical compliance with country-specific requirements. Please contact us today.
