FDA510(k)申請と早期許認可を目指すデータのそろえ方

米国で医療機器 (主に低中リスク品) を販売するためには市販前許可 (510(k) ) が必要となります。本セミナーでは510(k)の基礎的な事項と最新情報を踏まえた510(k)申請書の書き方について解説します。

1. 510(k) 基礎と最近の動向
   1. 510(k) とは
   2. 510(k) 最近の動向
      • 多機能デバイス製品の方針と考慮事項
      • 電子形式での医療機器の規制提出物の提供 など
2. 510(k) 申請資料
   1. Cover Sheet Forms
      1. Medical Device User Fee Cover Sheet (Form FDA 3601)
      2. CDRH Premarket Review Submission Cover Sheet
   2. What Others Can See
      1. 510(k) Cover Letter
      2. Indications for Use Statement
      3. 510(k) Summary
   3. Templated Sections
      1. Truthful and Accuracy Statement
      2. Class III Summary and Certification
      3. Financial Certification or Disclosure Statement
      4. Declarations of Conformity and Summary Reports
   4. Comparing Your Product vs. Predicate (s)
      1. Executive Summary
      2. Device Description
      3. Substantial Equivalence Discussion
   5. Ensuring Patient Safety
      1. Proposed Labeling
      2. Sterilization and Shelf Life
      3. Biocompatibility
   6. Software and Electronics
      1. Software
      2. Electromagnetic Compatibility and Electrical Safety
   7. Performance Testing
      1. Performance Testing – Bench
      2. Performance Testing – Animal
      3. Performance Testing – Clinical
• 質疑応答