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[FDA] Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new actions under the Pre-Cert Pilot Program to promote a more efficient framework for the review of safe and effective digital health innovations
  • 작성자 : 관리자
  • 작성일 : 2019-01-09 10:49:18
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Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency's new actions under the Pre-Cert Pilot Program to promote a more efficient framework for the review of 

safe and effective digital health innovations

7 January 2019


Digital technologies create new opportunities to transform health care and empower patients to make better informed decisions about their health. Digital tools are rapidly evolving, and to keep pace with this promising innovation, the FDA must modernize its approach to regulation. 

 

That’s why I announced in the Digital health Innovation Action Plan that the FDA would pilot a Digital Health Precertification (Pre-Cert) Program to make sure that patients continue to have access to new treatments that meet our gold standard for safety and effectiveness. Since that announcement, we’ve been advancing policies that reimagine our oversight of digital health tools to be more efficient and promote patient safety throughout the product lifecycle..:······(중략)

 

 

원문 바로보기 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm629306.htm

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