FDA has approved draft guidance clarifying how
benefit-risk determinations are made during premarket review of certain medical
devices, according to a press release.
“Clinical data is the foundation for determining
the safety and effectiveness of medical devices requiring FDA premarket
approval,” FDA Center for Devices and Radiological Health director
Jeffrey Shuren, MD, stated in the news release. “As medical devices
grow increasingly complex, many factors impact our benefit-risk determinations,
especially for PMA devices. This guidance aims to provide more clarity to
manufacturers about what factors we consider when making an approval
The guidance focuses on the regulatory pathway for
high-risk medical devices: premarket approval applications (PMAs).
Recommendations within the guidance are intended to improve predictability,
consistency and transparency of the premarket review process for applicable
devices, and could help manufacturers navigate the approval process more
easily, the release noted.
Safety and effectiveness data make up the FDA’s
review of PMAs, with safety data addressing risk and the device
manufacturer’s ability to mitigate such risk. Effectiveness data considers
benefits and other information in determining whether the benefits of using the
device outweigh the risks.
According to the release, however, safety and
effectiveness data alone may not provide a complete picture of the benefits and
risks involved. For this reason, FDA medical device reviewers examine factors
like the severity of the disease the product diagnoses or treats — as well
as whether or not alternative tests or treatments may be available. Reviewers
also might take into account whether a device should be considered new or
first-of-its-kind, especially if it treats a disease with no other treatment.
The guidance also proposes medical device reviewers use
a worksheet to document how they make benefit-risk determinations, the release
noted, adding that in certain cases such a document could be made public
post-approval — enhancing the transparency of the FDA’s
||Follow CardiologyToday.com on Twitter.