In Case You Missed It: Top 10 Gray Sheet Stories In February
This article was originally published in The Gray Sheet
Our coverage of the highly anticipated release of the revised ISO 13485 international medical device quality systems standard attracted the most attention from Gray Sheet readers last month. Also popular: stories about FDA photography during facility inspections, European postmarket surveillance reforms, and policy updates focused on human factors.
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The Justices were asked to review a Federal Circuit policy that limits the circumstances in which enhanced damages can be awarded in patent infringement cases for willful infringement.
Minimally invasive interspinous spacer did not get the support of an FDA advisory panel in the face of serious questions about Medtronic's study design.
Questions from companies and FDA reviewers about human factor design and data requirements for combination products continue to grow. In response, the agency has issued a draft guidance.