Shawn M. Schmitt
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Latest From Shawn M. Schmitt
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.
Intertwining design changes and document control is vital for manufacturers – especially for those whose creeping changes to a medical device can turn it into an altogether different product that requires a new 510(k) or PMA from the US FDA. Longtime agency investigator Laureen Geniusz weighs in on what she has seen in the field and offers other nuggets of design change advice.
In this week's Medtech Insight podcast, executive editor Shawn M. Schmitt and senior reporter Sue Darcey discuss recent reporting on efforts by US senators to control and stop Chinese researchers in the US from using their research jobs at the National Institutes of Health, and at American medical colleges and universities, to steal genomic data and share it with the Chinese government.
'Burn Them Out, Turn Them Over': Add Auditor Exhaustion, 'Boutique' Approach To The List Of Notified Body Challenges
From not enough notified bodies and auditors, to a slew of new or updated international standards and regulations coming into force, the medtech industry is facing a number of NB challenges – and now they can add auditor burnout as a concern. "Because some of these notified bodies have such huge demand, they're burning people out really fast," industry expert Kim Trautman says, noting that device-makers can expect to see "boutique" notified bodies popping up over the coming decade. Also: Johnson & Johnson's regulatory director explains how the dearth of notified bodies and auditors is affecting the global medical products giant.
In the only device-related warning letter released by the US FDA this week, a maker of duel lumen catheters was cited for quality systems, Medical Device Reporting and recall violations.
The US agency is still taking steps to shutter its Alternative Summary Reporting Program, despite an earlier soft commitment to end it by the end of last month.