FDA is seeking to rein in the device industry's interpretation of the "least burdensome" statutory provisions, which govern how much data regulators may ask for during pre-market reviews.
Article preview from "The Gray Sheet" - August 9, 2010
FDA is seeking to rein in the device industry's interpretation of the "least burdensome" statutory provisions, which govern how much data regulators may ask for during pre-market reviews.
Device companies have interpreted the provisions too broadly, hindering reviewers' ability to access information they need to clear or approve new products, FDA charges in a new report on science in regulatory decision-making,
The report was prepared by an FDA task force and released in conjunction with a highly anticipated report proposing reforms to the 510(k) pre-market notification program.
The science report attempts to address industry complaints that
FDA has become unpredictable in its regulatory demands, for
instance, shifting clinical requirements in the middle of a
pre-market review. The report also deals with the agency's own
concerns that it lacks the tools and expertise to keep up with
evolving science and communicate paradigm changes to companies.
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