510(k) Premarket Notification Submission Checklist
Use this checklist to ensure your medical device 510(k) submission is complete and compliant with FDA requirements.
Company/Organization Name
*
Contact Person Full Name
*
First Name
Last Name
Contact Email Address
*
example@example.com
Contact Phone Number
Please enter a valid phone number.
Format: (000) 000-0000.
Device Name (Trade or Proprietary Name)
*
Device Classification
*
Please Select
Class I
Class II
Class III
Other
Is this your first 510(k) submission for this device?
*
Yes
No
510(k) Submission Checklist
*
Rows
Included?
Cover Letter
1
Table of Contents
2
Truthful and Accurate Statement
3
Indications for Use Statement
4
Device Description
5
Predicate Device Information
6
Labeling (Instructions for Use, Package Labels)
7
Summary of Substantial Equivalence
8
Performance Testing (Bench, Animal, Clinical)
9
Sterilization and Shelf Life Information
10
Biocompatibility Data
11
Software Documentation (if applicable)
12
Risk Analysis
13
Electromagnetic Compatibility and Electrical Safety
14
Declaration of Conformity (if applicable)
15
Additional Comments or Notes
Signature of Responsible Party
*
Submit Checklist
Submit Checklist
Should be Empty: