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.
AdvaMed has filed comments with the EPA regarding proposed regulations of ethylene oxide and their impact on patient care.
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.
“I am honored to welcome Thierry Bernard as the new chair of the AdvaMedDx Board. With his decades of experience, Thierry brings a clear vision of the work we can accomplish, and I look forward to working with him.”
“Approaches to Increasing Diversity in Clinical Research and Addressing Health Inequities” offers key recommendations for device manufacturers and developers on steps they can take to increase diversity in clinical research and address health equity.
“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.”
The industry association says the shortage has become a serious, industry-wide problem for companies involved in manufacturing medical technologies.
Recent transportation challenges have affected the medtech industry’s ability to deliver healthcare products.
The medtech trade association condemned yesterday’s violence.
The IGNITE American Innovation Act aims to help small- and mid-sized businesses affected by the COVID-19 pandemic.