Many manufacturers may wonder what mechanism is most appropriate to receive marketing approval from the FDA.
Most Class I, II, or III device devices are approved through a premarket approval. A premarket notification (510k) is deemed legally an authorization to market a device, and is 'authorized for sale by FDA', not approved by the FDA.
Because approximately 80% of the devices currently marketed in the United States were authorized through a 510k, it is important for manufacturers to understand when and how to use this mechanism.
What kinds of devices require a 510k?
Those that don't require premarket approval
A 510k is necessary for devices that do not require a premarket approval.
Those that are equivalent to an existing device under certain circumstances
In order to use the 510k mechanism, the manufacturers must demonstrate that a device that they want to market is substantially equivalent to an existing device marketed before May 28, 1976, a device for which the classification has changed from Class III to Class II or I, or a device that has already been demonstrated to be substantially equivalent under another 510k.
A 510k is appropriate in situations when domestic manufacturers and specification manufacturers are looking to market a new device that is substantially equivalent to a device manufactured by a competitor.
Those manufactured outside the country
Foreign manufacturers looking to market a device that has already been approved overseas may also use the mechanism.
In some cases, a device that has already been marketed in the United States may require a new 501k. For instance, if manufacturers are repackaging or relabeling the device, they may need to submit a 501k if the labeling has been significantly changed or if changes to the device are likely to impact the safety or efficacy.
Similarly, manufacturers may need to submit a 510k if they are proposing to use a device for a purpose other than for what it was originally intended.
How to submit a device for clearance under a 510k
In order to submit a device for clearance under a 510k, manufacturers must determine what class the device is and verify that it qualifies for the 510k. To do this, they must search a classification database on the FDA website. Then they must use the 510k database on the FDA website to identify currently marketed devices to use as comparators.
Manufacturers should use the product classification code that they find in the 510k database to determine whether any standards or guidance documents apply to the device they want to market. After conducting the appropriate studies and preparing the documents, they will then submit them as part of the 510k.
The following information must be included as part of a 510k:
- A description of the device, including the models, components, and specifications.
- Biocompatibility data for devices coming into direct contact with patients.
- Software documentation for devices that use software. This should include information on how the software might cause or decrease hazards to the patient or person operating the device.
- Information on electrical safety for devices requiring electricity.
- Performance testing data intended to demonstrate equivalence to an existing device.
- Labeling information, such as the proposed labeling, manuals, and instructions for users.
As part of the 510k process, manufacturers must notify the FDA of their intent to market a substantially equivalent device at least 90 days in advance. The FDA will then evaluate whether the device is substantially equivalent. If they determine that the device is substantially equivalent to an existing device on the market, they will clear it for marketing.
Establishment registration
The FDA requires manufacturers to complete an establishment registration and pay an associated fee. If the manufacturer is located in a foreign country, the manufacturer must designate an agent in the United States to represent them. Once the device is cleared, the manufacturer must list the device in a public medical device database maintained by the FDA. This process helps to ensure that substantially equivalent devices make it to the market in an expedited manner.
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