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of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.
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FDA Ends Summary Reporting Program, Releases 20 Years Of Adverse Events, Vows To Make MAUDE 'User-Friendly'
The US FDA today formally shuttered its Alternative Summary Reporting (ASR) Program and released to the public millions of adverse event reports received by the agency between 1999 and 2019. The FDA also wants to make its Manufacturer and User Device Experience (MAUDE) database – where all adverse events are stored – easier to use.
FDA Quietly Sunsetting Summary Reporting Program For Adverse Events, Readies Public Release Of Millions Of Pre-2017 Summarized MDR Reports
The US FDA expects to turn the lights out on its 22-year-old Alternative Summary Reporting Program for adverse events at the end of May, the agency tells Medtech Insight. But it's the FDA's upcoming online release of millions of summarized Medical Device Reports sent to the agency between 1998 and 2017 that could have the tongues of industry – and the public – wagging.
Prompted by more than 41,000 adverse events tied to surgical staplers in less than a decade, the US FDA issued a draft guidance document on the devices and proposed an upclassification from class I to class II. The measures are to be discussed at a May advisory committee meeting.