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Author: Indre Larson | Date: July 4, 2022
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. But it has also created confusion for companies designing a consumer product 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, “what does it mean for the FDA to classify a medical device,” the agency looks at two major factors:
When addressing what it means for the FDA to classify a medical device, “intended use” and “indications for use” are deciding factors for consumer digital products. Indication of use is defined in Title 21 of the Code of Federal Regulations as the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including 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.
Device classification depends on the intended use of the device, 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. There are regulatory controls required, for all device classifications that must be met that are defined in Title 21 of the Code of Federal Regulations, 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, in the event there is no legally marketed predicate device, and 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, it means the FDA classifies that medical device as the highest risk to patients and/or users. These are devices that are used in supporting or sustaining human life, of substantial importance 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, most requiring a Premarket Approval (PMA) application usually involving clinical trials and data collection.
At Sterling, our FDA regulatory compliance consultants can help you understand what it means for the FDA to classify a medical device, whether you are working on a digital health product or other device. We will not only help you anticipate the class of your device, but also help you determine your regulatory pathway and achieve regulatory, quality, and clinical compliance with country-specific requirements. Please contact us today.
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