The following steps can be taken to determine whether or not a new 510(k) is necessary for your device:
1) Is it a control mechanism, operating principle, or energy type change?
- Control mechanism changes: A control mechanism is the manner by which the actions of a device are directed. Almost all changes in the control mechanism for a device could significantly affect safety and effectiveness. Therefore, such changes will usually require submission of a new 510(k). Changes of these types tend to be more revolutionary than evolutionary.
- Operating principle changes: Similar to a control mechanism change, a change in operating principle would also usually require submission of a new 510(k). Such changes may also be accompanied by significant labeling changes and, sometimes, by a need for operator retraining to ensure continued safe and effective operation.
- Energy type changes: Submission of a new 510(k) will usually be required for energy type changes. These changes include both energy output and input changes. A change from emitting microwave energy to radio frequency (RF) energy would be an example of an energy output change; this type of change would likely be part of a significant redesign. Such a change would normally be accompanied by significant labeling changes, including a new or expanded indication for use.
2) Is it a change to an “established category B” or “novel” sterilization method, does the change lower the sterility assurance level, or is it a change to how the device is provided?
Changes from “established category A” sterilization methods to “established category B” or “novel” sterilization methods generally require submission of a new 510(k). If the sterility assurance level (SAL) is lowered, manufacturers should consider whether device safety or effectiveness may be compromised by the new level. Note that changes to cleaning and disinfection processes for reprocessed devices can also affect the bioburden levels on a device, which may invalidate subsequent processing steps such as sterilization. For the purposes of this question, “how the device is provided” refers to whether the device is provided sterile or non-sterile, and to whether the device is provided for (1) single-patient, single-use, (2) single-patient, multi-use, or (3) multi-patient, multi-use.
3) Could the change significantly affect the performance or biocompatibility of the device?
Changes in the method of sterilization, cleaning, or disinfection have the potential to change material or performance characteristics of a device. This is particularly true of the properties of polymeric materials or surface coatings, resorbable materials, or animal-derived materials. Cleaning, disinfection, and/or sterilization changes may also affect the biocompatibility of a device. If a manufacturer determines their cleaning, disinfection, or sterilization change could significantly affect the performance or biocompatibility of the device, submission of a new 510(k) is likely required. Otherwise, it is unlikely submission of a new 510(k) is required as a result of this type of change.
4) Is the same method or protocol, as described in a previously cleared 510(k), used to support the change?
Generally, changes in device packaging or changes in the expiration date for use of a device do not require submission of a new 510(k). FDA relies on the QS regulation (21 CFR Part 820) to reasonably assure the safety and effectiveness of devices with these types of changes. This is true whether or not the manufacturer applies an expiration date because of package integrity considerations, e.g., sterility, or because of a finite shelf-life of the device. However, where methods or protocols that are not described in a previously cleared 510(k) are used to support new package integrity or shelf-life claims, submission of a new 510(k) is likely required.
5) Is it any other change in design (e.g. dimensions, performance specifications, wireless communication, components or accessories, or the patient/user interface)?
These types of design or engineering changes encompass everything from the routine specification changes necessary to maintain or improve device performance as a result of feedback from users, field or plant personnel, etc., up to and including significant product redesign. Some changes include:
- Dimension changes
- Device performance changes
- Wireless communication changes
- Components or accessories
- Changes in the human factors of the patient or user interface
6) Does the change significantly affect the use of the device?
As with a labeling change, if a design change significantly affects how a device may be used, submission of a new 510(k) is likely required. In the risk-based assessment, manufacturers should consider whether the design change increases the likelihood that the device will be used by a broader or different group of users who have less training regarding safe and effective use of the device (e.g. lay users instead of clinicians, or general practitioners instead of surgeons) and whether that design change affects the risk profile of the device. In deciding whether a design change that allows use of the device in a new environment could significantly affect the safety or effectiveness of the device, manufacturers should consider differences in environmental specifications such as:
- temperatures and humidity that might affect device operation;
- noises that might drown out the sound of auditory alarms;
- exposure to water, soils, or light that might affect device operation;
- presence of other devices or equipment that may cause electromagnetic interference; and
- possible use in magnetic resonance imaging (MRI)
7) Does a risk-based assessment of the changed device identify any new risks or significantly modified existing risks?
New risks, changes to the acceptability of previously identified risks, or changes to device features that may be critical to the device’s safe or effective operation will likely require submission of new 510(k)s. Manufacturers should carefully consider whether changing one aspect or feature of a device’s design might affect a seemingly unrelated aspect or feature. For instance, a dimensional or component change may affect the ability to reprocess a device or the ability to regulate the temperature of an electronic device. Manufacturers should evaluate these impacts of the change as part of their risk-based assessment.
8) Are clinical data necessary to evaluate safety or effectiveness for purposes of design validation?
Whenever a manufacturer recognizes that clinical data are needed because bench testing or simulations are not sufficient to assess the impact of the change on safety or effectiveness to validate the design change, submission of a new 510(k) is likely required. For the purposes of this question, clinical data does not include data used for purposes other than design validation, such as user or patient preference testing.
9) Do design verification and/or validation activities produce any unexpected issues of safety or effectiveness?
All changes to device design should undergo some level of design verification and/or validation or evaluation to ensure that the device continues to perform as intended. Manufacturers should make an initial risk-based assessment of whether a change requires submission of a new 510(k). If the manufacturer determines after an initial assessment that submission of a new 510(k) is not required, the manufacturer should conduct routine verification and validation activities to ensure that no new issues of safety or effectiveness are raised. If successful application of routine verification and validation activities confirms the initial assessment, manufacturers should proceed with the design change and document their assessment.