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Table of Contents
1. PURPOSE
2. DESCRIPTION OF THE DEVICE
3. FDA DEVICE CLASSIFICATION
3.1. Possible FDA product codes
3.2. Differences between available classifications and [your device name]
3.3. Possible predicate devices
4. TOOL TO DETERMINE RISK/BENEFIT PROFILE
5. REGISTRATION, LISTING AND QMS REQUIREMENTS PRIOR TO COMMERCIALIZATION
6. SUBMISSION OPTIONS
6.1. De Novo
6.2. 513(g) Request for Information
6.3. Pre-Sub Meeting
7. APPLICABLE STANDARDS AND TEST METHODS
8. APPLICABLE FDA GUIDANCE DOCUMENTS
9. CONCLUSIONS AND RECOMMENDATIONS
APPENDIX A – 21 CFR 820 ROLES & RESPONSIBILITIES
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