Many Class I and Class II medical devices are permitted to enter the U.S. market via the 510(k) premarket notification process.
Medical devices must be approved by the Food and Drug Administration (FDA) before they can be marketed to the public. The main method of gaining approval for a medical device from the FDA is a premarket approval (PMA). However, some devices don’t require a PMA. Devices that are similar enough to devices that are already on the market only require premarket notification, also known as a 510(k).
The 510(k) is a much simpler, easier, and cheaper submission to make to the FDA, as it is not for a new and therefore potentially riskier technology, but rather for something the FDA has seen before and found to be safe. The 510(k) does still require that the device be shown to be as safe and effective as something already on the market.
The Center for Devices and Radiological Health (CDRH) oversees the 510(k) premarket notification.
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Since 1906 with the signing of the Pure Food and Drugs Act, the Food and Drug Administration has regulated the development and distribution of products designed for human consumption. Decades later, in 1976, an amendment to the Federal Food Drug and Cosmetic Act of 1938 was passed: The Medical Device Amendment. This amendment was designed to assure the public that a medical device was reasonably safe, and established the three-tier class system that is still used today. The Medical Device Amendment also instituted post market requirements for medical devices, such as Good Manufacturing Practices (GMP), listing devices with the FDA, and reporting adverse effects.
The 1990 Safe Medical Devices Act further added to the post market to-do list for 510(k) products. Facilities such as hospitals and nursing homes also gained the requirement to report adverse effects related to medical devices. The Act also defined substantial equivalence, which is the determining factor for whether or not a 510(k) premarket notification is approved.
The major requirement for a 510(k) notification is that the product is “substantially equivalent” to an already approved product. The definition of “substantially equivalent” to a predicate product was confirmed in 1990 to be as follows:
If the FDA provides a letter finding the new device substantially equivalent to the previous device, the new device may then be legally marketed.
A company has the following options if the device is not found to be substantially equivalent:
A lack of substantial equivalency does not mean the medical device can never be marketed, it just means that the FDA did not find the product to be similar enough to a device they had already approved, and therefore they need more data in order to determine whether it is safe and effective. Of course, that potentially means a significant amount of additional safety and efficacy data that would cost a lot of money. Therefore, most who submit a 510(k) would prefer to avoid having to submit a PMA.
An important consideration for a medical device is who must submit a 510(k). For a single device there could be multiple submissions, depending on the manufacturers. The following entities must submit 510(k) premarket notifications:
In contrast, the following situations do not require the submission of a 510(k):
In order for any medical device to be marketed in the U.S. the FDA has a series of requirements designed to ensure their safety. These requirements are delineated in the Medical Device Amendments, and their applicability depends on the classification of the medical device in question.
Class I devices pose the least risk to human health. They are not meant to be life-sustaining or supporting, and can’t pose any unreasonable risk of injury or illness. Examples of Class I devices are Band-Aids and sterile gloves. Class I devices are required to adhere to General Controls as defined by the Medical Devices Act. General controls include parts of the Medical Devices Act that relate to adulteration; misbranding; device registration; premarket notification; banned devices; notification and repair, replacement and refund; records and reports; restricted devices; Good Manufacturing Practices (GMP). All medical devices must adhere to General Controls, though this is the only level of control required for Class I devices.
Class II devices pose a higher risk than Class I and therefore are subject to additional controls. The definition of a Class II device is one that requires these additional controls in order to maintain its safety. Called Special Controls, they include special labeling requirements, mandatory performance standards, and post market surveillance. Surgical robots, acupuncture needles, and powered wheelchairs are all Class II devices. Class II devices are also required to follow General Controls.
Class III devices are not eligible for the 510(k) pathway and instead must seek premarket approval, as they are considered to have the highest risk and may be life-sustaining or supporting.
All manufacturers of medical devices have requirements they must follow. For Class II and III devices and some Class I devices, this includes following design controls as laid out in 21 CFR 820.30. The entity submitting the product for 510(k) premarket notification must be able to provide the design control documentation to the FDA during a site inspection.
Changes made to the specifications for a medical device or changes to the manufacturing process may require a new 510(k) submission.
Devices that are designed to be substantially equivalent to products that are already on the market essentially have a pre-written blueprint for their approval by CDRH. The requirements for notifying the FDA prior to marketing a medical device have been changed over the decades, but they are all designed to protect the health and safety of people.
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