In early September, the Food and Drug Administration (FDA) released a draft outlining a new program designed to increase the safety for certain U.S. medical devices. It is a voluntary program that targets current diagnostics and treatments used for mortalities and morbidities that do not qualify for its Breakthrough Devices Program.
Called the Safer Technologies Program (STEP), it includes devices used for treating and diagnosing less serious and reversible conditions. Interested parties can request to be included in STEP by contacting the FDA for expedited development and prioritized reviews for regulatory submissions. The goal of this new program is to provide patients with more timely access to these devices and products while adhering to FDA regulatory standards.
Enacted in December 2018, the FDA’s voluntary Breakthrough Devices Program was designed to expedite the approval process and market clearance for certain medical devices and device-led combination products. These products help higher-risk patients with life-threatening and irreversible conditions with newer technologies, and the program was designed to streamline the processes and benefit both patients and manufacturers. Some of the methods used include senior management engagement, improved communications, and prioritized reviews. STEP takes the Breakthrough Program a step further by expanding it to include non-life-threatening diseases.
To qualify for STEP, devices must be ineligible for the Breakthrough Program and must be innovative enough to significantly improve benefit-risk profiles for treatments and diagnostics. Safety innovations are another consideration for acceptance into the program, and eligibility will depend on the device reducing the occurrence of a known use-related hazard, a user error, a known device failure mode, or a known serious adverse event.
To be considered, manufacturers must request inclusion via the FDA’s Pre-Submission Program. In the second phase for approval, the FDA will work to expedite device development through prioritized reviews, which includes preclinical testing. The guidelines state that, as resources permit, they intend to follow Breakthrough guidelines that also specify senior management involvement, timely communications, and early engagement on data development plans.
The Director of Public Citizen’s Health Research Group does not feel that STEP will significantly improve the approval processes for medical devices. He also pointed out that it will not alter the legal standards for reasonable assurance for safety and effectiveness that leads to premarket approvals. The FDA Device Chief feels that STEP will allow patients better access to safe, effective, and high-quality medical devices by streamlining the development, assessment, and review processes. He added that the program will generate the evidence needed to authorize these products to be marketed to the public.
If you or a loved one experienced injury or illness from an FDA-approved medical device, contact the experienced Philadelphia defective medical device lawyers at Brookman, Rosenberg, Brown & Sandler. Call us at 215-569-4000 or contact us online for a free consultation today. Located in Philadelphia, we serve clients throughout New Jersey and Pennsylvania, including Delaware County, Chester County, and Philadelphia County.