Good morning! Andrew Joseph here filling in for Megan.
You can reach me at andrew.joseph@statnews.com.
FDA looks to overhaul medical-device system
The FDA has announced a plan to revise the rules for approving most medical devices, including those around how a company developing a new device can rely on an older device’s safety data to make it to market. Experts have been calling for an overhaul to the decades-old system for years to ensure that new devices have up-to-date safety elements. Among the potential changes: publicly posting when a device’s approval is based on a device more than a decade old.
It’s been a big week in the medical device world, with the publication of a major investigation from the International Consortium of Investigative Journalists alleging that there have been nearly 83,000 deaths in the last decade suspected of being linked to medical devices. AdvaMed, a medical device trade group, said it is considering paid advertising to counter the investigation.
It’s been a big week in the medical device world, with the publication of a major investigation from the International Consortium of Investigative Journalists alleging that there have been nearly 83,000 deaths in the last decade suspected of being linked to medical devices. AdvaMed, a medical device trade group, said it is considering paid advertising to counter the investigation.
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