Table of Contents - Medical Device Academy
Table of ContentsThe first column (headed §) contains references to the 510(k) sections recommended in the FDA guidance document “Format for Traditional and Abbreviated 510(k)s” (2005).The next two columns refer to the Volumes and Documents in the eCopy submission and also to the way in which the paper file is organized. In the paper file, the Vol column refers to sub-divisions within a binder rather than to separate binders.§VolDocTopic11Acceptance Checklist for Traditional 510(k)s (RTA)21Table of Contents3Cover Sheets and Cover Letter131Medical Device User Fee Cover Sheet (Form FDA 3601)232CDRH Premarket Review Submission Cover Sheet (FDA Form 3514)233CDRH Premarket Review Submission Cover Sheet: Addendum to Section 2 Standards Cited334510(k) Cover Letter441Indications for Use Statement551510(k) Summary661Truthful and Accurate Statement771Class III Summary and Certification881Financial Certification or Disclosure Statement991Declarations of Conformity and Summary Reports10101Executive Summary11111Device Description12121Substantial Equivalence Discussion13131Proposed Labeling14141Sterilization and Shelf Life15151Biocompatibility16161Software17171Electromagnetic Compatibility and Electrical Safety18181Bench Performance Testing 19191Animal Performance Testing 20201Clinical Performance Testing ................
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