Perhaps you have an idea for a medical device that could revolutionize medical care in the US, or perhaps for an improvement that could increase a device's safety or effectiveness. Bringing an innovative device to the U.S. market can present many challenges but also rewards. The US Food and Drug Administration (FDA) wants to encourage improvements to the overall safety and effectiveness of medical devices, and has developed programs to help companies get their devices to market as quickly as possible: The Breakthrough Device (BTD) and the Safer Technologies Program (STeP) designations. If your device is designated under one of these programs, that opens opportunities for increased collaboration and alignment with FDA regulators prior to the marketing submission, as well as for prioritized review of marketing submissions. In this webinar, the presenter will help attendees develop a better understanding of the advantages of these programs, how to determine if a device qualifies, and when to apply for these designations.
▶ 일자: 2024년 02월 07일 오전 9시 CST 기준
(한국시간 02월 08일 자정)
▶ 교육신청은 아래 링크를 통해 진행
US FDA Breakthrough Device (BTD) and Safer Technologies Program (STeP) Designations | Emergo by UL
US FDA Breakthrough Device (BTD) and Safer Technologies Program (STeP) Designations
Join our Emergo by UL expert for a complimentary webinar on Breakthrough Device (BTD) and Safer Technologies Program (STeP) designations.
www.emergobyul.com
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