The following steps can be taken to determine whether or not a new 510(k) is necessary for your device:

Is it a change in the indications for use statement?

Changes in the indications for use statement raise more concern than any other aspect of labeling. In fact, most labeling changes that affect the substance, meaning, or scope of the indications for use could significantly affect safety or effectiveness and will require submission of a new 510(k). Changes that clarify the indications without affecting the substance or meaning of the indications usually do not require submission of a new 510(k).

Is it a change from a device labeled for single use only to a device labeled as reusable?

Changing a device labeled for single use only to a device that is labeled as reusable typically could significantly affect the safety or effectiveness and would likely require submission of a new 510(k). Changing a device labeled for reuse to single use only, however, would likely not require submission of a new 510(k) because a single use is a limitation of the previously cleared indications for multiple uses, and the risks of single use were inherently considered within the risks of multiple uses.

Is it a change from prescription (Rx) to over the counter (OTC) use?

Changing a device labeled for prescription use only to a device that is labeled for OTC use typically could significantly affect the safety or effectiveness and would likely require submission of a new 510(k). Changing a device labeled for OTC use to prescription use, however, would likely not require submission of a new 510(k) because it is unlikely that the associated labeling changes could significantly affect the safety or effectiveness of the device.

Is it a change to the device name or a change solely to improve readability or clarity?

Changes to the device name or description that are consistent with the cleared indications for use typically do not significantly affect the safety or effectiveness and would likely not require submission of a new 510(k). Changes that are solely to improve readability or clarity that are consistent with the cleared indications for use typically do not significantly affect the safety or effectiveness and likely would not require submission of a new 510(k).

Does the change describe a new disease,condition, or patient population that the device is intended for use in diagnosing, treating, preventing, curing or mitigating?

Differences in indications for use should be analyzed to explain how they are or are not critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device, and how the differences do or do not affect the safety and effectiveness of the device. The criticality of these types of changes and their direct effect on safety and effectiveness means that a change to add a new disease, condition, or patient population likely requires submission of a new 510(k). To evaluate whether a change in patient population is a new and distinguishable patient population, manufacturers should compare the demographics, diagnosis, prognosis, comorbidity, and potential for complications of the patient population described in the previously cleared 510(k) to those of the modified patient population.

Does a risk-based assessment of the changed device identify any new risks or significantly modified existing risks? What types of changes could significantly affect the device’s risk profile?

• Changes to the type of joint, organ, bone, vasculature, or tissue applied to or interacted with, regardless of the section of labeling in which this information is contained
• Changes in user or use environment
• Changes in frequency or duration of use
• Changes concerning the compatibility or interoperability of a device with other devices, components, or accessories
• Changes from a general use to a more specific use

7)    Does the change add or delete a contraindication?

Changes in the labeled contraindications for device use generally could significantly affect safety or effectiveness of a device; however, FDA recognizes that, in general, the addition of a contraindication based on new information is important to public health. Thus, FDA does not intend to object if manufacturers add new contraindications to their labeling and notify existing users of their device as expeditiously as possible whenever a pressing public health need arises. In this situation, the new labeling should be submitted to FDA as part of a new 510(k) that is prominently labeled “change being effected” (CBE). Deletion or modification of a contraindication also usually requires submission of a new 510(k) prior to effecting the change, because this type of labeling change typically changes the indications for use in a way that could significantly affect safety or effectiveness.

8)    Is it a change in warnings or precautions?

In order to facilitate a continuous upgrading in device labeling, manufacturers should monitor device usage and promptly revise the warnings and precautions section(s) based on user experience. Events that precipitate changes of this type may be those reported under the medical device reporting regulation (MDR), 21 CFR Part 803. Submission of new 510(k)s for such labeling changes are generally not required.

9)    Could the change affect the directions for use of the device?

Device labeling may be changed for a multitude of reasons. Many labeling changes result from attempts to clarify labeling. Manufacturers should consider whether the change is intended to or could affect how the device is used in practice. Manufacturers should evaluate labeling changes to determine whether the change affects the directions for use of the device, including IVD labeling required under 21 CFR 809.10.

Some changes include:

• Adding additional or new instructions on how to interpret diagnostic data
• Adding a new procedural technique not described in the original labeling
• Use of a product for a duration/frequency that is different than what is described in the labeling
• Changing from labeling a device as non-sterile to labeling it as sterile or vice versa
• Adding instructions for device use in a new patient population not described in the original indications for use
• Adding instructions for device use in a different type of joint, organ, bone, vasculature, or tissue.

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