In order to market a medical device in the U.S., a manufacturer must go through one of two evaluation processes: a Premarket Notification [510(k)] (if not pardoned by a 510(k)), or a Premarket Approval (PMA). Most medical devices that are commercially distributed in the United States are approved by way of a premarket notification [510(k)]. In some cases, neither a 510(k) nor a PMA is required for devices that were legally marketed prior to May 28, 1976.
The 510(k) document is a pre-market application document filed with the FDA to demonstrate that the device sought to be marketed is as safe and effective as a legally marketed device not subject to Premarket Approval (PMA), i.e., it is a substantially equivalent device ( substantially equivalent). The applicant must compare the device under application with one or more similar devices currently on the U.S. market and reach a conclusion that it is substantially equivalent. A legally marketed device is a device that was legally marketed before May 28, 1976 (pre-marketed device), or a device that was classified in Class II or I from a Class III device, or a device that was found to be equivalent to such a device through the 510(k) process, or a device that was established through an automated evaluation of the definition of a Class III device. Equivalent devices are referred to as "predicate device(s)". The applicant must submit descriptive data and, if necessary, performance data to show that the device is the equivalent of a predicate device. Again, the 510(k) data is data showing similarity, i.e., the extent to which the new device is equivalent to the predicate device.
FDA Equivalent Devices
Instead of requiring a reasonable demonstration of safety and efficacy, as in the case of a PMA, 510(k) requires a demonstration of an equivalent device. An equivalent device is a new device that is as safe and effective as a predicate device.
A device is considered to be an equivalent device when compared to a predicate device if it:
- has the same purpose of use and the same technical properties as the predicate device; or
- has the same technical properties as the predicate device has the same purpose of use, has different technical properties, but does not have increased safety and efficacy concerns, and the certifier certifies that the device is as safe and effective as a legally marketed device.
The term equivalent device does not mean that the new device must be identical to the predicate devices. Equivalent devices are about purpose of use, design, energy used or delivered, materials, performance, safety, efficacy, labeling, biocompatibility, standards and other characteristics that can be applied.
A device may not be marketed until the applicant has received an order declaring it to be an equivalent device. Once the device is determined to be an equivalent device, it can then be marketed in the United States. If the FDA determines that the device is not an equivalent device, the applicant may submit another 510(k) document with new data, file a reclassification request, or submit a premarket approval application (PMA). A finding of an equivalent device is usually made within 90 days, based on the information submitted by the applicant.
Who must file a 510(k)
The Food, Drug, and Cosmetic (FD&C) Action Committee and the 510(k) regulations at 21 CFR 807 don't specifically state who must file a 510(k)-anyone can. They do, however, specify which actions, such as introducing a device into the U.S. market, require a 510(k) application.
Based on the behavior specified, the 510(k)s that must be filed with the FDA are shown below:
1) Domestic manufacturers who introduce devices into the U.S. market;
If a finished device manufacturer assembles a device according to their own specifications and markets the device in the U.S., then a 510(k) must be filed. However, device component manufacturers are not required to file a 510(k) unless the components are sold to end users as replacement parts. Contract manufacturers, companies that assemble devices under contract according to other specifications, are not required to file a 510(k).
2) Specifiers who introduce devices into the U.S. market;
The FDA reviews specifiers almost as much as it reviews manufacturers. The specifier is the person who develops the specification for the finished device, but the device is manufactured under contract by another company. Therefore, the specification developer, not the contract manufacturer, needs to file a 510(k).
3) Repackagers or relabelers who change the labeling or operate in a way that significantly affects the device;
If a repackager or relabeler significantly changes the labeling or affects other conditions of the device, a premarket notification may be required to be filed. At this point, you must determine whether the labeling has been significantly altered by modifying the guidelines, removing or adding warnings, contraindications, etc., and whether the packaging operation is capable of altering the conditions of the device. However, most repackagers or relabelers are not required to file a 510(k).
4) The foreign manufacturer/exporter or the U.S. agent of the foreign manufacturer/exporter who introduced the device into the U.S. market.
When a 510(k)
A 510(k) is required to be filed in the following circumstances:
1) First commercial distribution (listing). Anyone wishing to sell a medical device in the United States after May 28, 1976 (the effective date of the medical device amendments made by the FD&C Act) is required to file a 510(k) application at least 90 days prior to marketing the device. If the device was not marketed by your company prior to May 28, 1976, a 510(k) is required to be filed.
2) Proposing a different purpose of use for a marketed device. 510(k) specification (21 CFR 807) specifically requires a premarket notification for major changes in the purpose of use. The purpose of use is stated in the labeling or advertising claims for the device. However, most changes require the filing of a 510(k) if the intent to use has not changed in its entirety.
3) A change or improvement in a marketed device, if the change is capable of significantly affecting the safety or effectiveness of the device.
The applicant is responsible for determining whether the improvement is capable of significantly affecting the safety or effectiveness of the device. Whatever conclusion is reached, a record is made, and this record is able to be reflected in the device master record, and the change control record under the requirements of the Code of Practice for the Quality Management of Medical Devices. If questioned, the applicant will be able to demonstrate that the change was evaluated.
A new, complete 510(k) filing is required when there is a change or modification to an existing device that significantly affects the safety or effectiveness of the device, or when the guidelines for the marketed device are completely new or different from the original.
When a 510(k) is not required
A 510(k) is not required in the following situations:
1. A 510(k) is not required if a device manufacturer sells an unfinished device to another company for further processing that includes parts for use in the assembly of devices by other companies. However, a 510(k) is required if the parts produced are to be sold directly to the end user as replacement parts.
2. A 510(k) is not required to evaluate or test a device if the device being produced will not be marketed or commercially distributed. This includes clinical evaluations. If the device is manufactured to conduct clinical trials, it may be governed by the Investigational Device Amnesty (IDE) regulations.
3. Distributors are not required to file a 510(k) if they are distributing devices manufactured domestically by another company. A Distributor can place a "Distributed by ABC Firm" label on the device and sell it to end users without filing a 510(k).
4. In most cases, if there is no significant change in the existing labeling or condition of the device, then the repackager or relabeler does not require a 510(k) to be filed.
5. If the device was legally marketed prior to May 28, 1976, it is not required to file a 510(k) unless it has been modified or there has been a change in the purpose for which it is to be used. These devices are referred to as "grandfathered".
6. An importer of a foreign-made device is not required to file a 510(k) if:
a. the 510(k) has already been filed by the foreign manufacturer and marketing approval has been granted, or
b. the 510(k) has already been filed by the importer on behalf of the foreign manufacturer and marketing approval has been granted. If an importer submits a 510(k) on behalf of a foreign manufacturer, then all other importers of the same device from the same foreign manufacturer (the 510(k) holder) are not required to submit a 510(k) for this device.
Certain Class I or Class II devices may be marketed for the first time without filing a 510(k). Specifications for Class I and Class II amnestied devices can be found in Medical Device Amnesties