On October 24, 2017, the FDA announced new steps that it is taking to promote beneficial medical device innovation.
First, the FDA completed a first qualification of a medical device development tool (MDDT). The newly qualified MDDT is a 23-item questionnaire that measures health information of patients with heart failure. According to the release, the tool has the potential to help engineers more efficiently and accurately quantify how much their device could actually improve a patient’s quality of life. The FDA expects to evaluate and qualify more medical device development tools in the coming months.
The FDA also released three new guidance documents relating to medical devices. The first is a draft guidance that describes the “Breakthrough Devices Program,” a program intended to help patients more quickly access devices that effectively diagnose or treat life-threatening or irreversibly debilitating diseases or conditions. As outlined in the draft guidance, the program enables a more agile pre-submission process for breakthrough devices.
The other two new guidance documents aim to help innovators determine when they need to submit a new 510(k) prior to making a change to a legally-marketed device that is subject to premarket notification (510(k)) requirements. According to the release, these policies will help innovators introduce iterative improvements that can improve a product’s safety and performance by establishing a brighter line regarding when the FDA needs to review and clear these changes in advance. The FDA clarifies that it is not changing its review standard. Instead, they assert that the new policies enhance predictability and consistency for innovators who are deciding when to submit new 510(k)s.