Draft guidance on when to submit a 510(k) for significant changes to an existing device is more specific than previous guidance but needs to clarify the test for a significant change, manufacturers’ groups said in public comments.
Ruey Dempsey, vice president of technology and regulatory affairs for the Advanced Medical Technology Association (AdvaMed), said the draft guidance conflates two different tests for determining whether a new 510(k) is needed.
He said that under current regulations on device modifications, the two tests include one for a technology change that could significantly affect safety or effectiveness, and one for a major change or modification in intended use. As a result, classification of a new device turns on two distinct characteristics that are evaluated differently.
In its regulations, the FDA “clearly recognized that technology changes require a [safety and effectiveness] test to determine if such changes require a new premarket notification, and intended-use changes require a separate test to determine whether a change in intended use may result in a new device classification,” he said. “In this draft guidance, it appears FDA is conflating two distinct regulatory concepts” by applying the “safety and effectiveness test” to the question of change in intended use.
The draft guidance issued Aug. 5 addresses the extent to which an existing 510(k) clearance covers labeling or product changes before a new notification is required. A companion document covers the same subject for software changes (). FDA received 21 comments on the draft guidance by the time the comment period closed Nov. 7.
Ralph Hall of Leavitt Partners said on behalf of the 510(k) Coalition that the final version of the guidance should specify that a new 510(k) is likely needed — rather than absolutely needed, as the draft guidance states — if a modification is “a major change in intended use” or “a change that could significantly affect safety or effectiveness.”
In addition, according to Hall, the final guidance should explicitly define “cumulative” device changes in a way that does not require every change to be separately documented and evaluated.
He said each time manufacturers make a change to a device, it should be compared to the most recently cleared device. “When the manufacturer compares the most recent proposed and validated modified device to the device in the last cleared 510(k), the manufacturer is in effect evaluating the cumulative impact of all changes since the last cleared 510(k),” he said.
Hall also said the Coalition supports the FDA’s focus on using the Quality Systems Regulation processes “as a critical methodological tool” in determining whether a new 510(k) is needed. “We believe that risk assessments and the use of validation and verification processes are important for prioritizing whether a modification could significantly affect safety and effectiveness while not overburdening industry or the FDA with additional 510(k)s being submitted,” he said.
Finally, the Medical Device Manufacturer’s Association said the draft guidance inconsistently applies the concept of risk management in assessing the impact of a change to a device — or, in some cases, fails to apply it at all. “MDMA strongly believes that a risk-based assessment should be included consistently throughout the guidance, including the examples cited which outline the process companies should undertake to determine whether a new 510(k) is appropriate,” the group said.