FDA 发布 IDE 申请电子提交模板指南草案
Electronic Submission Template for Investigational Device Exemption (IDE) Applications; Draft Guidance for Sponsors and Food and Drug Administration Staff; Availability
FDA 发布针对申办方及 FDA 工作人员的 IDE 申请电子提交模板指南草案。该草案文件已在 Federal Register 上公布，具体内容因网站访问限制未能获取。
Due to aggressive automated scraping of FederalRegister.gov and eCFR.gov, programmatic access to these sites is limited to access to our extensive developer APIs. Please visit FederalRegister.gov API documentation or eCFR.gov API documentation to learn more about how to access the API.
Your request has been flagged as potentially automated. If you are human user receiving this message, please complete the CAPTCHA (bot test) below and click "Request Access". You may occassionally be asked to complete the CAPTCHA again, this is normal and part of our security measures.
An official website of the United States government.
If you experiencing issues with the CAPTCHA or want to request a wider IP range, you can use the "Site Help" button found in the lower, right of this page to make a request.
来源：Federal Register · FDA · federalregister.gov