The FDA has released new guidelines to aid medical device regulation and assess the effectiveness of cardiovascular products.
Regulations
According to a statement from FDA commissioner Scott Gottlieb, the organisation is setting out new medical device development tools that will measure the safety and performance of devices so they provide the required benefits to patients.
Gottlieb outlined how the aim was to enable patients and providers to have efficient access to new and innovative medical products that meet the FDA’s gold standard for safety and effectiveness.
“We’re advancing these goals as part of the Medical Innovation Access Plan that I announced earlier this year,” he said.
As one part of that effort, the FDA is announcing some additional steps to promote beneficial medical device innovation.
The FDA knows that medical device technology evolves quickly. “Often it’s the case that small modifications help provide incremental but meaningful improvements to products. Over time, these cumulative advances are consolidated into more noticeable advances in the performances of different technologies. Therefore it’s important for the FDA to enable innovators to have the flexibility to efficiently make these kinds of small modifications. At the same time, the FDA needs to establish modern tools and benchmarks for measuring the safety and performance of devices to make sure they’re delivering the expected benefits to patients,” said Gottlieb.
To achieve this the FDA has taken steps towards these goals.
This first measure is a medical device development tool (MDDT) to provide a more objective platform for developing devices in a key area of medicine – cardiovascular health.
“Fostering the creation and validation of development tools that can be used to provide more efficient and accurate ways to measure risk and benefit, as part of the medical product development process, is a key goal of the FDA. At the FDA, we’re undertaking a comprehensive policy effort to facilitate the development and validation of these kinds of medical device development tools,” said Gottlieb’s statement
The MDDT is a 23-item questionnaire that measures health information that is reported directly by patients with heart failure. It can be used to measure a heart failure patient’s health status, including clinical symptoms and the physical and social limitations caused by this condition. It has the potential to help engineers designing heart failure devices to more efficiently and accurately quantify how much their device could actually improve a patient’s quality of life. By qualifying the tool under the FDA’s new, voluntary program, it will make it easier for product developers to rely on the outputs of this newly qualified tool as part of their development plans. Innovators can trust in advance that the agency has already found the outputs of these measures to be reliable.
The FDA says it expects to evaluate and qualify more medical device development tools in the coming months. One area in which it feels there may be opportunity is wearable technologies as it believes these tools have the potential to provide fundamentally better ways of measuring clinical outcomes, like how a device or even a drug affects outcomes that relate to physical performance or the function and output of different organ systems.
The FDA has also released three new guidance documents related to medical devices. The first is a draft guidance delineating the FDA’s new ‘Breakthrough Devices Program,’ which was created by the 21st Century Cures Act passed by Congress last year. Building on the Expedited Access Pathway (EAP) program, this new scheme is intended to help patients more quickly access certain devices that more effectively diagnose or treat life-threatening or irreversibly debilitating diseases or conditions, such as technologies that have no alternative or that offer a significant advantage over FDA-cleared or approved alternatives. The program would enable a more agile pre-submission process for breakthrough devices.
There are also two additional piece of guidance that will help innovators determine when they need to submit a new 510(k) prior to making a change to a legally-marketed device subject to premarket notification (510(k)) requirements. These policies will help innovators introduce iterative improvements that can improve a product’s safety and performance by establishing a clearer line regarding when the FDA needs to review and clear these changes in advance.