The Food and Drug Administration issued draft guidance (PDF) to clarify how the federal agency determines benefit and risk during pre-market approvals of some medical devices.
FDA draft guidance clarifies PMA process
According to the draft document, the FDA evaluates safety and effectiveness data to determine risk and benefits, as well as other factors that include the severity of the disease that the product will treat or diagnose, whether an alternative is available, and whether the product is a “first-of-a-kind” technology.
In addition, the draft guidance recommends that a worksheet showing FDA reviewers' benefit-risk determinations could be made public, following a product approval.
The guidance applies to devices subject to the pre-market approval application (PMA) process and some devices which can be cleared using the agency's fast-track 510(k) process. The FDA requires high-risk medical devices to go through the more stringent PMA process, which requires clinical data, unless they are considered “substantially equivalent” to products already on the market.
“As medical devices grow increasingly complex, many factors impact our benefit-risk determinations, especially for PMA devices,” Dr. Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said in a statement. “This guidance aims to provide more clarity to manufacturers about what factors we consider when making an approval decision.”
The PMA process has been criticized by manufacturers as being slow and unpredictable. The agency said in the news release that the guidance is intended to improve “predictability, consistency and transparency.”
It is the first time that the FDA has released a draft guidance regarding benefit-risk determinations for these devices. The agency is accepting comments for 90 days.
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