The document cites a range of issues that could tie to product safety, such as water and air quality, and maintenance of a sterile work environment. But the company says it is working with US FDA on its remediation plan and states that no known product safety issues are linked to the observations.
A 58-page, 14-observation FDA Form 483 issued after a recent US FDA inspection of Zimmer Biomet Holdings Inc. ’s Warsaw, Ind., plant is likely to lead to a warning letter and ongoing remediation efforts, one analysis states.
The firm issued a statement Dec. 14 acknowledging receiving the FDA-483 form. Analysts at Wells Fargo Securities obtained the form...
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Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.
The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
Researchers at Johns Hopkins have used a robotic system to autonomously perform a key part of gallbladder surgery without a surgeon's hand. Lead author Axel Krieger says it could take five to 10 years before an autonomous robotic system will reach human trials and expects regulatory hurdles.
