What Are Class III Medical Devices? And What Marketplaces Need to Know
In 1976, medical devices were categorized into classes based on the level of risk the device presented to its user and the impact it could potentially have on consumer health. Discover what Class III medical devices are and the regulatory environment surrounding them. Then contact us for a quick strategy session.
What Are Class III Medical Devices?
A Class III medical device is legally defined by the Medical Device Amendments of 1976 as those “for use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health,” or which “presents a potential unreasonable risk of illness or injury to the subject.” Additionally, the US Food and Drug Administration (FDA) further clarifies that Class III medical devices should be “subject to premarket approval requirements,” as opposed to Class I and II devices which may be brought to market with significantly lessened FDA review and scrutiny.
The Medical Device Amendments of 1976 Established the Three Classes
The Federal Food, Drug, and Cosmetics Act (FDCA) was amended by the Medical Device Amendments of 1976. The amended FDCA established three classes for medical devices based on the level of control necessary to ensure their safety and efficacy.
The three classes of medical devices are as follows:
Class I – Medical devices in this category demonstrate “low to moderate risk” and are typically less technologically advanced devices. Example: Elastic bandages.
Class II – Most devices that pose “moderate to high risk” fall into this class. Example: Wheelchairs.
Class III – These devices are considered “high risk” and require “general controls and premarket approval”. Example: breast implants.
The FDA Requires a Premarket Approval Application (PMA) for Class III Medical Devices
Devices are assigned to “one of three regulatory classes,” which determine whether and what kind of FDA clearance is required to market. If the device was manufactured after 1976 and is classified as Class III, the FDA will require the manufacturer to submit a premarket approval application (PMA). Notably, nearly all Class III medical devices also require a prescription.
According to the FDA, the agency has “classified and described over 1,700 distinct types of devices and organized them in the [Code of Federal Regulations] into 16 medical specialty ‘panels.’”
Examples of Problematic Class III Medical Devices
Class III medical devices are sometimes sold illegally on e-commerce platforms, and LegitScript often flags them for review during our monitoring. We flag these devices for various reasons: some have not been vetted by the proper regulatory authorities, some are being used or sold without proper licensure, and some have been shown to pose an inherent threat to consumer safety.
Below are examples of common problematic Class III medical devices we encounter:
- HIV tests and hepatitis B tests: Often these tests have been shipped internationally and have not been authorized by the FDA. We also sometimes see counterfeit versions of tests being sold on marketplaces.
- Shockwave devices for erectile dysfunction (ED): These products sometimes lack proper regulatory vetting and/or lack appropriate consumer instruction.
- Ear candles: These products, which require an open flame near a person’s head, have been cited by the FDA for their high risk of consumer harm.
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LegitScript Marketplace Monitoring Identifies Class III Medical Devices
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