To help answer this common question from device manufacturers, FDA issued the following two draft guidances for public comment on August 8, 2016:
- “Deciding When to Submit a 510(k) for a Change to an Existing Device”, and
- “Deciding When to Submit a 510(k) for a Software Change to an Existing Device”.
The first draft guidance, “Deciding When to Submit a 510(k) for a Change to an Existing Device”, is an update from the original 1997 guidance. A couple of key guiding principles are highlighted in this guidance. First, it is noted that any device changes made with the intent to significantly improve device safety and effectiveness likely require a new 510(k). Specific examples may be device changes in response to known risks or adverse events. It should also be noted, however, that FDA has several other guidances to address device changes in relation to violations or recalls, such as:
- Blue Book Memorandum K95-1 “510(k) Requirements During Firm-Initiated Recalls” (November 21, 1995) and
- “Distinguishing Medical Device Recalls from Medical Device Enhancements” (October 15, 2014).
Changes that are not intended to significantly affect the device’s safety or effectiveness should then be evaluated using the guidance to determine whether the change could significantly affect the device safety or effectiveness (either positively or negatively) and, therefore, require a new 510(k) per 21 CFR 807.81(a)(3)(i). A key aspect in determining whether a device modification could significantly affect the safety or effectiveness of a device is the conductance of a risk analysis to evaluate all new risks and any changes to existing risks that result from the modification. Verification and validation activities should be used to confirm the initial risk assessment and adjust any initial decision made on whether a new 510(k) is required.
The guidance then goes into specific examples, including flow charts, for labeling changes; technology, engineering, and performance changes; materials changes; and changes specifics for in vitro diagnostic devices to provide recommendations on whether a new 510(k) may be needed. All applicable flowcharts should be taken into account for any unintended consequences of the device change or how combinations of changes may affect the device’s safety and effectiveness. For example, a change in sterilization may not only affect the sterility of the device, but also may unintentionally change the device materials. Consequently, changes to the device materials may also unintentionally affect device performance.
Another key aspect to evaluating device changes FDA points out in their new draft guidance is that all potential changes should be compared back to the most recent cleared version of the device—this is important since device manufacturers may commonly make changes that do not require submission of a new 510(k). If it is determined that a new device change or modification requires a new 510(k), all changes made to the device since its most recent clearance are expected to be discussed in the new 510(k).
FDA’s guidance on software changes has similar guiding principles as the general guidance; however, a software-specific flowchart is provided to help assess common software changes and the need for a new 510(k). The guidance states that a new 510(k) is not likely for changes made solely to strengthen cybersecurity or those that only restore the device to the specifications of the most recently cleared device. Since software is used in such a wide variety of medical devices and the impact of software changes is not always clear, FDA states that “the goal of the draft guidance is to provide examples of software changes that clearly could have a significant impact on the safety or effectiveness of the device based on functional changes to the device’s operation”. The draft guidance also discusses additional factors specifically related to software, including general code changes that are “not necessarily intended to change function” (e.g., “code maintenance” or “infrastructure” modifications).
Public comments for both guidances can be submitted until November 7, 2016 at http://www.regulations.gov.