510k Submission Process Chart
PHASE 1- INITIAL DETAILS |
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DOCUMENTATION REQUIREMENTS |
SCOPE OF WORK (I3CGLOBAL) |
SCOPE OF WORK (CLIENT) |
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1.1 | 510(k) Summary |
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1.2 | Indication For Use Statement (FDA Form 3881) |
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1.3 | Device Description |
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PHASE 2- TESTING AND SUPPORTING DETAILS |
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DOCUMENTATION REQUIREMENTS |
SCOPE OF WORK (I3CGLOBAL) |
SCOPE OF WORK (CLIENT) |
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2.1 | Biocompatibility Testing (if applicable) |
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2.2 | Performance Testing- Bench |
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2.3 | Sterilization and Shelf life (if applicable) | ||
2.4 | Software (if applicable) | ||
2.5 | Electromagnetic Compatibility and electrical safety (if applicable) | ||
2.6 | Performance Testing- Animal | If required,
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2.7 | Performance Testing- Clinical | ||
2.8 | Proposed Labelling |
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PHASE 3- SUBSTANTIAL EQUIVALENCE DOCUMENTS AND INITIAL SUBMISSION TO FDA |
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DOCUMENTATION REQUIREMENTS |
SCOPE OF WORK (I3CGLOBAL) |
SCOPE OF WORK (CLIENT) |
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3.1 | CDRH Premarket Review Submission Cover Sheet (FDA Form 3514) |
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3.2 | Class III Summary and Certification |
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3.3 | Financial Certification or Disclosure statement |
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3.4 | Executive Summary |
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3.5 | Substantial Equivalence Discussion |
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3.6 | 510(k) Cover Letter |
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3.7 | Truthful and Accuracy Statement |
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3.8 | Declarations of conformity and Summary report |
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3.9 | MDFUSC (FDA Form 3601) |
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PHASE 4- POST SUBMISSION SUPPORT |
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DOCUMENTATION REQUIREMENTS |
SCOPE OF WORK (I3CGLOBAL) |
SCOPE OF WORK (CLIENT) |
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4.1 | Day 1: FDA receives 510(k) application | ||
4.2 | By day 7: Acknowledgement letter sent by FDA. If there are any issues with the application, a Hold letter is sent | ||
4.3 | By day 15: Acceptance review is conducted and FDA informs the applicant if the submission has been accepted for Substantive Review or placed on RTA hold. |
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4.4 | By day 60: Substantive review completed and will inform the applicant if any Additional Information (AI) is needed or Interactive Review is required to clarify any pending issues. |
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4.5 | By day 90: 510(k) Decision letter is issued. If the device is found to be substantially equivalent to the chosen predicate, the device is said to be 510(k) cleared. | ||
4.6 | Establishment Registration and Device Listing |
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