Many manufacturers may wonder what mechanism is most appropriate to receive marketing approval from the Food and Drug Administration (FDA). Most Class I, II, or III devices are approved through either a premarket approval or a premarket notification (510(k)). Because approximately 80% of the devices currently marketed in the United States were approved through a 510(k), it is important for manufacturers to understand when and how to use this mechanism.
A 510(k) is necessary for devices that do not require a premarket approval. In order to use the 510(k) 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 510(k).
A 510(k) 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. 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 510(k). For instance, if manufacturers are repackaging or relabeling the device, they may need to submit a 510(k) 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 510(k) if they are proposing to use a device for a purpose other than for what it was originally intended.
In order to submit a device for clearance under a 510(k), manufacturers must determine what class the device is and verify that it qualifies for the 510(k). To do this they must search a classification database on the FDA’s website. Then they must use the 510(k) database on the FDA’s website to identify currently marketed devices to use as comparators. Manufacturers should use the product classification code that they find in the 510(k) 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 510(k).
The following information must be included as part of a 510(k):
- 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 case 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 510(k) process, manufacturers must notify the FDA of their intent to market and substantially equivalent device at least 90 days in advance. The FDA will then evaluate whether the device is substantially equivalent. If hey determine that the device is substantially equivalent to an existing device on the market, they will clear it for marketing.
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.
For further reading:
http://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfPCD/classification.cfm
http://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfPMN/pmn.cfm