Industry, US FDA Defend Innovation As A Force For Good
Executive Summary
At this year's MedTech Conference, AdvaMed said it will go the distance to defend industry against unfair attacks, and it downplayed assertions made in The Bleeding Edge documentary. FDA's Jeff Shuren made the case that supporting innovation and protecting patient safety go hand-in-hand.
You may also be interested in...
Public Interest Groups Will Leverage ‘Bleeding Edge’ Lessons To Push For Device Safety Changes
Public health organizations including the Facebook group ASHES/E-Sisters, and the National Center for Health Research, are pushing for wider distribution of and a big impact from the "The Bleeding Edge" Netflix documentary. They tell Medtech Insight that they will continued to lobby Congress and US FDA to put more safety regulations and protocols into place for devices.
Top Medtech Lobbyist Doubts Legislative Repercussions Of New Netflix Documentary
AdvaMed's top lobbyist says a new documentary critical of the medical device industry and US FDA's device review pathways is unlikely to result in Congressional action. However, the group is talking to members on Capitol Hill to make sure they fully understand the context within which devices are reviewed and marketed.
FDA Eyes Upclassification, Labeling Guidance To Address Stapler Risks
The US agency sent a letter to health-care providers spotlighting its analysis of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.