FDA’s New Safety Reports Raise Tort Risks For Device Cos.

Law360, New York (March 8, 2013, 6:28 PM EST) -- The U.S. Food and Drug Administration's attempt to force medical device makers to report a wide array of product safety improvements, potentially including routine upgrades, marks a major escalation of oversight that could hand trial lawyers new ammunition in personal injury suits, according to experts.

In draft guidance issued Feb. 22, the FDA said any “product enhancement” intended to reduce health risks must be reported, even if the product isn’t being recalled. Until now, such reports have applied to equipment and software that have already been...
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