In September 2023, the FDA published several new draft guidance documents for Class II, moderate-risk devices as part of the agency’s agenda to modernize the 510(k) program. One of these is a draft guidance for the evidentiary standards for device implants, which when completed will provide additional clarity regarding the types of clinical and non-clinical evidence that will be required for these regulatory submissions.
In 2018, the FDA initiated a series of steps to improve medical device safety and performance, a plan developed with a
primary focus on the 510(k) program. This plan was undertaken because of the rapid evolution of medical technology in the decades since the passage of the 1976 Medical Device Amendments. The Safer Technologies Program (STeP) was part of the 2018 device safety action plan, an accelerated review program for applications that offer a safer version of existing devices whereas the new implants evidence draft guidance requires only that a new 510(k) application demonstrate the same level of safety as the predicate. The draft guidance is intended to clarify when clinical testing and human factors testing will be required for implants, as well as the types of bench testing that would be expected in that device’s 510(k) submission.
The FDA expects that submitters will provide a variety of data from clinical and/or non-clinical sources to support the claim that the implant is as safe and effective as the predicate device. However, the type and amount of data will vary by the type of device and the degree to which the device differs from the referenced predicate device.
It is important to note that the implants evidence draft guidance applies to devices that will remain implanted continuously for at least 30 days, but sponsors are advised to consider the provisions of the guidance for implants expected to remain in the human body for less than 30 days. The intended duration of implantation will have some impact on the types of data the FDA will expect to accompany premarket applications, but a device that will be resorbed into the human body may call for a different approach to testing relative to a device that will remain intact for the life of the device or patient.
The guidance features several general categories of non-clinical evaluation, such as testing for biocompatibility, electromagnetic compatibility, sterility and pyrogenicity. Devices that feature software should demonstrate adequate cybersecurity, but the hardware may have to be designed to ensure it can be adequately updated for cybersecurity over the device’s expected term of use. One possible method of controlling for this is the installation of excess memory in the device’s electronic hardware, which would allow for updates to software architecture that may be required to accommodate future cybersecurity updates.
The implants evidence draft states that labeling should advise the implanting physician about the requirement to inform the patient about measures the patient can take to reduce the risks associated with long-term implantation. The FDA also recommends that the manufacturer provide the physician with safety information materials to present to the patient. Product labels and warnings continue to play a key role in mitigating risk.
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