'Least Burdensome' Provisions Revisited In FDA Regulatory Science Report

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.

'Least Burdensome' Provisions Revisited In FDA Regulatory Science Report

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.

Least-Burdensome Scrutiny

According to the report, if FDA is to improve its ability to obtain high-quality scientific information about products, it must clarify to industry its interpretation of the least burdensome provisions.

The provisions, added to the Food, Drug and Cosmetic Act in 1997, say FDA will consider the least burdensome means of demonstrating reasonable assurance of safety and effectiveness (for PMAs), or substantial equivalence (for 510(k)s), and make data requests accordingly.

The provisions are meant to eliminate unjustified burdens on industry, but instead "have created a culture in which it is difficult for pre-market reviewers to obtain a sufficient level of evidence to consistently provide reasonable assurance of a device's safety and effectiveness," the report states.

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