510(k) Documents
-21 CFR 807 Subpart E
关于510(k)的文件提交可在21 CFR 807 SubpartE 中确认，可通过下方的链接进行确认。
文件必须提交至下列地址，并在Cover Letter中标明"510(k) Notification " 。
• Medical Device User Fee Cover Sheet
• CDRH Premarket Review Submission Cover Sheet
• Cover Letter
• Table of Contents
• 510(k) summary or 510(k) Statement
• Indication for use
• Truthful and Accuracy Statement
• Information on sterilization, biocompatibility, expiration date, etc.,
• Description of the device
• Proposed label, labeling, advertisements
• Comparison with a predicate device(s)
CFR - Code of Federal Regulations Title 21
[Code of Federal Regulations] [Title 21, Volume 8] [Revised as of April 1, 2020] [CITE: 21CFR807] TITLE 21--FOOD AND DRUGSCHAPTER I--FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H - MEDICAL DEVICES PART 807ESTABLISHMENT
www.accessdata.fda.gov
Address,
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Control Center (DCC) – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
* 在实际进行Review时，需缴纳510(k) User Fee。 User Fee的情况可以在以下链接中进行确认。
Medical Device User Fee Amendments (MDUFA)
Medical device companies pay fees to the FDA when they register their establishments and list their devices with the agency.
www.fda.gov
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