Tag Archives: AdvaMed

Regulations

Regulatory Advocacy: Amplifying Your Voice

By MedTech Intelligence Staff
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Regulations

Companies have several avenues available to share their input on and help shape MedTech regulation. At the 2023 MedTech Regulatory Intelligence Summit, former FDA CDRH member Steven Silverman, and Patterson Shafer, strategic advisor to FDA, offered guidance on how to establish credibility with FDA and the most effective ways to make your voice heard.

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EPA Announces Proposed Rules To Reduce Ethylene Oxide Exposure

By MedTech Intelligence Staff
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If finalized, EPA’s proposals are estimated to cut EtO emissions to the air from commercial sterilization facilities by 80% per year and apply more protective standards to control those emissions under the law. But MedTech advocates are concerned that the EPA is overlooking the controls already in place and a lack of alternatives that could lead to patient risks.

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Five Finalists of Annual Pediatric Medical Device Competition Announced

“Addressing unmet needs across pediatric populations is critical to advancing children’s health, and we are delighted to once again work with pioneering companies that seek to bridge this care gap.”

“Addressing unmet needs across pediatric populations is critical to advancing children’s health, and we are delighted to once again work with pioneering companies that seek to bridge this care gap.”

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