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US FDA 510(K)

Home 510k Submission Process Chart

Phase 1 – Initial Details

Requirements

Scope of I3CGlobal

Scope of 510(k) Applicant

1. Intended use
  • Send requisition for Intended use

 

  • Identification of product code
  • Provide an appropriate intended use of the non-active device.

 

  • Confirmation of product code
2. Indications of Use Statement
(Form 3881)
  • Send requisition for indications for use.

 

  • Filling of the form based on details provided by the 510(k) applicant.

 

  • Assist the applicant to frame the appropriate Indications for use statement based on the intended use and product code if required.
  • Provide appropriate indications for use of the non-active device in compliance with the intended use.

 

  • Provide Device Name.

 

 

 

  • Confirm the type of Device i.e., Prescription Use or Over the Counter Use.
3. Device Description
  • Send requisition regarding device description to the applicant through mail communication.

 

  • Review of device description details shared by the applicant.
  • Preparation and documentation of Device Description template as per FDA premarket submission Guidance.
  • Provide the basic details of the non-active devices which include :
  • features of the non-active device like sizes, accessories etc.
  • Summary of the functions of the device
  •  A detailed description of the device with technology, principal, and mode of action
  • Performance testing_ Bench summary table with results for each test.
  • Formulation with CAS number, percentage ratio proportions, and supplier details
  • Material safety data sheet
  • Statement related to biocompatibility
  • diagrams or images if any
  • Manufacturing process steps involved.
4. Predicate Device
  • Identify and share the potential predicate device based on product code and device description.
  • Approval of a suitable predicate device.
5. 510(K) Summary
  • Develop a template.

 

  • Fill in the manufacturer and device details.
  • Fills the predicate device details
  • 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.

Phase 2 – Non-active Device Supporting Documentation based on Intended Use & Indications for use

Document Requirements Scope of I3CGlobal Scope of 510(k) Applicant
2.1 Device Drawing
  • Send requisition for device drawing of non-active devices.

 

  • Review and document for 510(k) submission
  • Provide Device drawing
2.2 Material Safety Datasheet
  • Send requisition for Material safety data sheet of crucial formulation ingredients.

 

  • Review and document for 510(k) submission.
  • Provide Material safety data sheet of crucial formulation ingredients
2.3 Manufacturing Flow chart
  • Send requisition for Manufacturing Flow chart including all stages of the process in detail.

 

  • Review and document for 510(k) submission.
  • Provide the Manufacturing Flow chart
2.4 Proposed Labelling
  • Send a requisition for the Proposed Inner box label and Proposed outer box label.
  • Review the User Manual and promotional material shared by the applicant.

 

  • Review and document for 510(k) submission.
  • Provide both the Proposed Inner box label and Proposed outer box label.
2.5 Sterilization
(If the device is sterile)
  • Send a requisition for the concerned with the sterilization process.

 

  • Review the documents and provide corrections if any.
  • Review and document for 510(k) submission.
  • Provide the sterilization-related study plan and reports.

 

  • Provide the suggested corrected document.
2.6 Shelf Life
  • Requisition for shelf-life Study Plan and Reports.

 

  • Review and document for 510(k) submission
  • Provide the shelf life Study Plan and Reports.

 

2.7 Biocompatibility
  • Send a requisition for the estimated biocompatibility endpoints of the device.
  • Review the study plans prior to test performance if tests are initiated.
  • Review the study reports prior to conversion to the final draft.
  • Document for 510(k) submission.
  • Provide the confirmation of biocompatibility estimated endpoints of the device.
  • Provide the study plans for review.
  • Provide the study report for review.
  • Provide the final copy

 

2.8 Performance Testing_ Bench
  • Send a requisition of performance tests to be conducted with standards recommended by FDA.
  • Review the test reports.
  • Documents the final test reports for 510(k) submission.
  • Provide the confirmation of the performance tests to be conducted.
  • Share the performance study test reports of all recommended tests by the FDA.

 

2.9 Risk Management File
(Recommended only based on the risk associated with the device not mandatory for every non-active device as per FDA)
  • Send a requisition for Risk Management File and Instruct to document Risk management Plan and Report identifying risk hazards, risk assessment and demonstrating that risks have been appropriately mitigated and risk management report.
  • Provide a template of Risk management plan and risk management report covering all the device-related risks on request from the applicant.
  • Review the Risk Management File data containing Plan and Report shared by the applicant and suggest the necessary corrections to document for 510(k) submission.

 

  • Review and document for 510(k) submission.
  • Provide a Risk management plan, risk assessment demonstrating that risks have been appropriately mitigated and risk management report covering all risk elements associated with device.

 

  • Provide the suggested corrected document.

 

Phase 3 – Initial Documents and Substantial Equivalence Documents

Document Requirements

Scope of I3CGlobal

Scope of 510(k) Applicant

3.1 CDRH Premarket Review Submission Cover Sheet (FDA Form 3514)
  • Fill the FDA Form 3514 based on the details provided by the applicant.

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 Software
  • Not necessary as the device does not include software.

3.5 Electromagnetic Compatibility and Electric Safety
  • Not necessary as the device does not include any electric/power source.

3.6 Performance Testing_ Animal
  • Not necessary as most of the non-active device does not require animal testing.

3.7 Performance Testing_ Clinical
  • Not necessary as most of the non-active device does not require clinical testing.

3.4 Executive Summary
  • Create a template and prepare the document.
  • Justify any differences between the proposed device and the predicate device.
  • Comparative study between the proposed device and the predicate device chosen.

3.5 Substantial Equivalence Discussion
  • Create a template and prepare the document.
  • Comparative study between the proposed device and predicate device chose.

Phase 4 – Administrative Documents

Document Requirements

Scope of I3CGlobal

Scope of 510(k) Applicant

4.1 510(k) Cover Letter
  • Prepare and provide a template to the applicant covering all details required for cover letter and share to the applicant instructing to use the letterhead and provide the authorized person signature.
  • The document printed on company letterhead must be signed and hard copy couriered to the US office.
  • Provide a Soft copy of signed 510(k) cover letter for 510(k)documentation.
4.2 Truthful and Accuracy Statement
  • Provide a template with the required content to be mentioned and document for submission.
  • The document signed by the contact person at the firm should be provided.
4.3 Declarations of conformity and Summary report
  • Create a template listing and prepare the document.
  • The document signed by the contact person at the firm should be provided.
4.4 MDFUSC
(FDA Form 3601)
  • Create medical device user fee cover sheet and PIN.
  • Make payment to FDA. (Before submission of 510(k) file.)

 

Phase 5 – RTA Checklist and E-Copy

Document Requirements

Scope of I3CGlobal

Scope of 510(k) Applicant

5.1 RTA Checklist
  • Create an RTA Checklist Template based on type of submission.
  • Fill the checklist and ensure that mentioned documents to be submitted to the FDA and share to the applicant.
  • Approval of Verification of RTA Checklist.
5.2 E-Copy
  • Arrangement of submission folder sections as per FDA Guidance and share to the applicant.
  • Convert to e-copy.
  • E-copy submission to US Agent
  • Approval of Final submission Folder documentation.