1. 更新510(k) Submission Process說明,包括Log-in and Acknowledgement ProcessAcceptance ReviewSubstantive Review510(k) Decision LetterTimeline of Communication with 510(k) Applicants

2. 公告兩份指引草案(Draft Guidance)Blood Glucose Monitoring Test Systems for Prescription Point-of-Care UseSelf-Monitoring Blood Glucose Test Systems for Over-the-Counter Use

3. 諮議委員會:2014/2/20 Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

4. 公告Automatic Class III Designation (De Novo)的評估方式。

5. FDA Voice Blog新增「Setting the Bar for Blood Glucose Meter Performance」。

6. 公告20139月及10月份PMA Final Decisions

參考資料:

U.S. FDA CDRHNews http://www.fda.gov/MedicalDevices/NewsEvents/News/default.htm#

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  • 請問有對eCopy和eSubmission的介紹嗎?
  • 您好,
    若您需要相關資訊,建議您可以利用以下網址,供您參考。
    http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm221506.htm
    Frequently Asked Questions on eSubmitter and OIVD
    eSubmitter-eCopies Tool

    M.D. 於 2014/01/22 17:05 回覆