Table of Contents - Medical Devices Group



Table of ContentsThe first column “Vol” refers to the volumes of the submission. The volumes match the De Novo sections recommended in the FDA guidance. A 21st volume has been added for inclusion of an optional RTA checklist. The second column “Doc” refers to the document numbers, and the third column “Pgs” indicates how many pages are included in each document.VolDocPgsTopic11Medical Device User Fee Cover Sheet (Form FDA 3601)212Table of Contents – In Progress3Cover Sheets and Cover Letter15CDRH Premarket Review Submission Cover Sheet (FDA Form 3514)2De Novo Cover Letter3Certification Regarding Confidentiality of this De Novo4Truthful and Accurate Statement5QYY1234 PreSub mtg minutes6CDRH Premarket Review Submission Cover Sheet: Addendum to Section 2 Standards Cited4Comparison of Intended Use & Indications for Use1Comparison of Intended Use2Indications for Use FDA Form 388151Alternate Practices & Procedures61Classification Summary71Classification Information and Supporting Data8Financial Certification or Disclosure Statement1Financial Certifications & Disclosures Summary2FDA Form 3454 – Submitted to client for completion3FDA Form 3455 for [Investigator Name] – Submitted to client for completion4FDA Form 3455 for [Investigator Name] – Submitted to client for completion9Declarations of Conformity and Summary Reports1Declarations of Conformity Overview2FDA Form 3654 for ASTM D4169101Device Description111Executive Summary121Benefit-Risk Consideration 13Proposed Labeling1Labeling Overview2Draft Label3Draft IFU4Draft Surgical Technique Guide5Placeholder for training videos found only in the eCopy14Sterilization and Shelf Life1Sterilization and Shelf-life Overview2Sterilization Validation Report3Accelerated Age Testing15Biocompatibility1Biocompatibility Overview2Cytotoxicity3Sensitization4Irritation or Intracutaneous Reactivity5Acute Systemic Toxicity (recommended)6Material Mediated Pyrogenicity (recommended)16Software1Software Overview2Level of Concern3Software Description4Device Hazard Analysis5Software Requirements Specification (SRS)6Architecture Design Chart7Software Design Specification8Traceability Analysis9Software Development Environment Description10Verification and Validation Documentation11Revision Level History12Unresolved Anomalies13Cybersecurity Summary17Electromagnetic Compatibility and Electrical Safety1EMC and Electrical Safety Overview2EMC Testing Report3Electrical Safety Testing Report18Bench Performance Testing 1Benchtop Performance Testing Overview2Cadaveric Testing Report3Shipping Validation191Animal Performance Testing 20Clinical Performance Testing 1Clinical Performance Testing Overview2Clinical Study Protocol3Clinical Summary Report4Placeholder for Statistical Data21116Draft RTA Checklist for De Novo Request – Rob will complete this lastMISC FILESTraining Videos.zipxxx.mp4STATISTICAL DATAClinical Statistical Data.zipxxx.xxx[Note: This note should be deleted before you submit. If you need more than one binder, instead a break in the table and duplicate the header from the first table to the second table. The color coding has the following meaning: red = not started, yellow = in-progress, green = done, blue = requires signature). Remove the color coding before creating a PDF as well.] ................
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