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Mashup Score: 0FDA: ‘We have had a very loud voice’ on EtO - 5 month(s) ago
The agency said it is working closely with the Environmental Protection Agency, which is slated to implement a final rule in March limiting ethylene oxide emissions for medical device sterilizers.
Source: www.medtechdive.comCategories: Healthcare Professionals, Latest HeadlinesTweet
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Mashup Score: 0FDA prioritizes guidance on AI, cybersecurity, pulse oximeters in stacked schedule for 2024 - 5 month(s) ago
The administration is ramping up production of medtech guidance, adding 18 draft documents to the list of priorities for the upcoming financial year.
Source: www.medtechdive.comCategories: Healthcare Professionals, Latest HeadlinesTweet
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Mashup Score: 0FDA Forms Digital Health Advisory Committee - 5 month(s) ago
FDA forms a new Digital Health Advisory Committee to explore the complex, scientific and technical issues related to digital health…
Source: hitconsultant.netCategories: Healthcare Professionals, Latest HeadlinesTweet
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Mashup Score: 0So why is the medical device lobby suing the Library of Congress? - 6 month(s) ago
It turns out the U.S. Library of Congress isn’t just the country’s oldest federal cultural institution, nor simply the home of a lovely Beaux-Arts reading room on Capitol Hill. | The Library of Congress has recently become a battleground over the right to repair, including for high-tech imaging machines and surgical robots.
Source: www.fiercebiotech.comCategories: Healthcare Professionals, Latest HeadlinesTweet
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Mashup Score: 0FDA finalizes guidance on cybersecurity for medical devices - 6 month(s) ago
Congress granted the agency authority to deny premarket submissions that lack cybersecurity information, starting in October.
Source: www.medtechdive.comCategories: Healthcare Professionals, Latest HeadlinesTweet
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Mashup Score: 0
Agency scientists flagged numerous issues with Brainstorm’s stem cell treatment ahead of a high-profile Wednesday meeting of expert FDA advisers.
Source: www.healthcaredive.comCategories: Healthcare Professionals, Latest HeadlinesTweet
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Mashup Score: 0Intarcia’s diabetes drug-device combo voted down again by FDA panel - 6 month(s) ago
The 19-member advisory committee unanimously voted against Intarcia in the review, citing cardiovascular and kidney safety concerns.
Source: www.medtechdive.comCategories: Healthcare Professionals, Latest HeadlinesTweet
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Mashup Score: 0
The FDA outlined deadlines for actions it will take, including creating a mechanism for working with regulatory partners.
Source: www.medtechdive.comCategories: Healthcare Professionals, Latest HeadlinesTweet
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Mashup Score: 0
The agency chose not to make some major requested revisions, such as including metals in the scope of the guidance.
Source: www.medtechdive.comCategories: Healthcare Professionals, Latest HeadlinesTweet
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Mashup Score: 0Court order gives teeth to EPA's deadline for EtO rule changes - 7 month(s) ago
A looming deadline for changes to ethylene oxide (EtO) regulations has new urgency under a consent decree approved by a federal judge.
Categories: Future of Medicine, Latest HeadlinesTweet
#FDA: ‘We have had a very loud voice’ on #EtO | #sterilization #medicaldevices #regulatory https://t.co/kbO9ieqm82