Follow Us:

510k Submission Process Chart

PHASE 1- INITIAL DETAILS

DOCUMENTATION REQUIREMENTS

SCOPE OF WORK (I3CGLOBAL)

SCOPE OF WORK (CLIENT)

1.1 510(k) Summary
  • Create a template and prepare the document.
  • Identification of predicate device.
  • Justify any differences between the proposed device and predicate device
  • Provide details regarding the manufacturer- name, address, contact person at the company, contact number etc.
  • Provide details of medical device like indications of use, the material of construction, any claims etc.
  • Approval of a suitable predicate device.
1.2 Indication For Use Statement
(FDA Form 3881)
  • The form is filled based on the details provided by the client.
1.3 Device Description
  • Create template.
  • Prepare the manufacturing process description.
  • Prepare the device description document.
  • Basic details of the medical device like different components and its purpose, any chemical used, different variants/ models, sizes etc. should be provided.
  • Medical device image and manufacturing flow chart to be provided.
  • Device drawing with the dimensions marked to be provided.
  • The MSDS and supplier details of the raw materials should be given.
  • Software architecture if applicable

 

 

PHASE 2- TESTING AND SUPPORTING DETAILS

DOCUMENTATION REQUIREMENTS

SCOPE OF WORK (I3CGLOBAL)

SCOPE OF WORK (CLIENT)

2.1 Biocompatibility Testing (if applicable)
  • Create template.
  • Identification of tests and the applicable standards.
  • Provide a list of details to be included in the plan and report.
  • Review of study plan and report.
  • Prepare the document.
  • A study plan should be provided for the tests identified.
  • Initiate the studies as early as possible, since biocompatibility studies may take 3-4 months for completion.
  • Provide study reports once the tests are completed.
2.2 Performance Testing- Bench
  • Create template.
  • Identification of tests and the applicable standards.
  • Provide a list of details to be included in the plan and report.
  • Review of study plan and report.
  • Prepare the document.
  • A study plan should be provided for the tests identified.
  • Provide study reports once the tests are completed.
  • Software Development Plan
  • Software Requirements Analysis
  • Software Integration & Testing
  • Software Configuration Management
  • Software Release
  • Software System Testing
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,

  • Create template.
  • Identification of tests and the applicable standards.
  • Provide a list of details to be included in the plan and report.
  • Review of study plan and report.
  • Prepare the document.
  • A study plan should be provided for the tests identified.
  • Provide study reports once the tests are completed.
2.7 Performance Testing- Clinical
2.8 Proposed Labelling
  • Create template.
  • Identify the labelling requirements to be met.
  • Review of the labelling materials provided.
  • Prepare the proposed labelling document.
  • The primary box label and other labelling materials are to be provided.

 

 

PHASE 3- SUBSTANTIAL EQUIVALENCE DOCUMENTS AND INITIAL SUBMISSION TO FDA

DOCUMENTATION REQUIREMENTS

SCOPE OF WORK (I3CGLOBAL)

SCOPE OF WORK (CLIENT)

3.1 CDRH Premarket Review Submission Cover Sheet (FDA Form 3514)
  • FDA Form 3514 is filled based on the details provided.
3.2 Class III Summary and Certification
  • Not necessary if clinical studies are not required.
3.3 Financial Certification or Disclosure statement
  • Not necessary if clinical studies are not required.
3.4 Executive Summary
  • Create a template and prepare the document.
  • Justify any differences between the proposed device and predicate device.
  • Comparative study between the proposed device and predicate device chose.
3.5 Substantial Equivalence Discussion
  • Create a template and prepare the document.
  • Comparative study between the proposed device and predicate device chose.
3.6 510(k) Cover Letter
  • Create template and prepare the cover letter
  • The document printed on company letterhead has to be signed and couriered to the US office.
3.7 Truthful and Accuracy Statement
  • Create a template and prepare the document.
  • The document signed by the contact person at the firm should be provided.
3.8 Declarations of conformity and Summary report
  • Create a template and prepare the document.
  • The document signed by the contact person at the firm should be provided.
3.9 MDFUSC (FDA Form 3601)
  • Create medical device user fee cover sheet and PIN.
  • Make payment to FDA. (Before submission of 510(k) file.)

 

 

PHASE 4- POST SUBMISSION SUPPORT

DOCUMENTATION REQUIREMENTS

SCOPE OF WORK (I3CGLOBAL)

SCOPE OF WORK (CLIENT)

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.
  • Resubmit the file with additional information in case of RTA.
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.
  • Prepare additional information response for doubts FDA may have about the medical device.
  • The AI response is submitted with justifications for the questions asked by FDA.
  • Any corrections suggested by FDA to the 510(k) documents are also made.
  • Any additional documents required for preparing the additional information response is to be provided.
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
  • US Agent Confirmation
  • FDA account creation
  • Device Listing
  • Annual fee payment