Jeff Shuren
The FDA has issued draft guidance titled “safer technologies programme for medical devices”, which is a voluntary programme that—a press release reports—is expected to significantly improve the safety of available treatments or diagnostic devices for diseases or conditions that are less serious than those eligible for the agency’s Breakthrough Devices programme but the use of which may be associated with serious or life-threatening risks.
The safer technologies programme, as described in the FDA’s 2018 Medical Device and Safety Action Plan, aims to encourage innovation towards safer medical devices and was modelled after the Breakthrough Devices programme. According to the press release, as agency resources permit, the safer technologies programme will include features such as interactive and timely communications with the FDA, review team support, senior management engagement and prioritised review.
The FDA believes this interactive and expedited feedback may reduce the total time to develop a device and achieve marketing authorisation, while still meeting the agency’s gold standard for safety and effectiveness. The press release reports states that advances in safety and innovation “are both important priorities for the agency and improvements in these areas are expected to result in timely access to devices that can increase quality of life and health benefits for patients, while still providing reasonable assurances of both safety and effectiveness”.
Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, comments: “Because technology continues to advance, patients are benefitting from more innovative medical devices that can help improve their health and even save their lives. Safety and innovation are both important priorities for the agency. Improvements in each of these areas are expected to result in increased quality of life and health benefits for patients, while simultaneously providing a reasonable assurance of both safety and effectiveness. To promote these goals, today we are issuing a draft guidance on a new voluntary pathway for certain medical devices and device-led combination products that do not otherwise meet the criteria for our Breakthrough Devices programme, but through innovative designs, have the potential to be significantly safer than currently available treatments or medical diagnostics. We believe the safer technologies programme for medical devices will help ensure that we’re giving patients timely access to safe, effective and high-quality medical devices by expediting their development, assessment and review, and by facilitating the generation of the robust evidence required to support product marketing authorizations. We will do this without changing our statutory standards, data requirements or quality of review.”
Devices and device-led combination products are eligible for this program if they are subject to review under a premarket approval application (PMA), De Novo classification request, or premarket notification (510(k)), and meet program eligibility factors as described in the guidance.
Following this announcement, the FDA revealed that, as a first step toward implementation of the recently established safety and performance based pathway for medical devices, it is issuing draft guidances outlining the recommended premarket performance criteria and testing methodologies for four specific types of devices. These are anticipated to be the first device types eligible for the new, voluntary premarket notification pathway to market devices, which was first announced in 2018 and finalised through guidance earlier this year. The initial device types being considered for eligibility for the Safety and Performance Based Pathway under the draft guidances issued today include:
- Conventional foley catheters
- Cutaneous electrodes for reporting purposes
- Orthopaedic non-spinal metallic bone screws and washers
