AdvaMed Commends FDA Focus on Unmet Public Health Needs
WASHINGTON , D.C. th Janet Trunzo, executive vice president for technology and regulatory affairs for the Advanced Medical Technology Association (AdvaMed), released the following statement today on FDA's public workshop on "Identifying Unmet Public Health Needs and Facilitating Innovation in Medical Device Development":
(Media-Newswire.com) - WASHINGTON , D.C. – Janet Trunzo, executive vice president for technology and regulatory affairs for the Advanced Medical Technology Association ( AdvaMed ), released the following statement today on FDA’s public workshop on “Identifying Unmet Public Health Needs and Facilitating Innovation in Medical Device Development”:
“AdvaMed commends FDA for holding today’s workshop to explore unmet public health needs and what can be done to facilitate medical technology innovation to address those needs. The medical technology industry is committed to providing solutions to the health challenges faced by patients around the world, particularly orphan and pediatric populations.
“AdvaMed and its member companies have analyzed the various regulatory and reimbursement obstacles that prevent the development of medical advancements to address unmet public health needs and have developed a number of practical recommendations that we believe would go a long way to ensuring those needs are met.
“Among the recommendations proposed by AdvaMed, we urge FDA to:
· Develop general guidance for its humanitarian device exemption program outlining appropriate types and levels of data necessary for approval. Lack of guidance ultimately hinders the use of the HDE program as a path to market for devices that treat or diagnose diseases and conditions that affect fewer than 4000 patients, including pediatric populations.
· Make greater use of regulatory tools and adaptive clinical trial designs that take into consideration the reduced sample size associated with orphan and pediatric diseases and conditions. For example, FDA could approve certain devices based on smaller confirmatory trials in conjunction with a long-term registry requirement, either for an individual device or for certain device types.
· Create an orphan and pediatric ombudsman within the agency’s device center. Currently, no one person within the center has either the responsibility or expertise to assist and counsel manufacturers or other interested stakeholders on how to utilize existing regulatory pathways to receive marketing approval for orphan and pediatric diseases and conditions.
“We look forward to further discussing these and other recommendations we have developed with FDA and other stakeholders in the hopes of improving patient access to advanced medical technologies that will address unmet public health needs.”
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AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.
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