Non-active Device 510k Flow Chart

1.1

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

1.2

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.

1.3

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.

1.4

Predicate Device

• Identify and share the potential predicate device based on product code and device description.

• Approval of a suitable predicate device.

1.5

510(K) Summary

• Prepare a template.
• Fill in the manufacturer and device details.
• Fills the predicate device details
• Prepare a comparative table and writeup the justification for similarities and differences

• Provide details regarding the manufacturer- name, address, contact person at the company, contact, number etc.
• Provide details of non-active medical devices like indications of use, the material of construction, any claims etc.

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 both the Proposed Inner box label and the proposed outer box label and provide recommendations as per FDA guidelines.
• Provide Instructions and guidance for the User manual documentation
• Review the User Manual and promotional material shared by the applicant and guide the recommendations as per USFDA guidelines.
• Send a requisition for an Implant card (If an Implant device).
• Provide guidance and instructions in Implant card documentation.
• Review and document for 510(k) submission.

• Provide both the Proposed Inner box label and Proposed outer box label.
• Provide the user manual for review, following the instructions as recommended.
• Provide the Implant card as recommended (if recommended by FDA in case of Orthopedic Implants)

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

Transportation &Packaging

• Send a requisition for Packaging and transportation Validation study plan and reports.
• Review the packaging and transportation validation study plans and report and share the corrections if any.

• Provide packaging and transportation validation study plans and reports.

2.8

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

2.9

Performance Testing_ Bench

• Send a requisition of a device-specific list of performance tests to be conducted with standards recommended by the FDA.
• Review the test plan before testing (If testing has not been performed yet).
• Provide the gap assessment study in case of an existing test plan and reports if applicable.
• Prepare a detailed Performance test summary report.
• Recommend justification for non-performed test as per FDA recommendation.
• Prepare a detailed packaging description document.
• Documents the final test reports for 510(k) submission.

• Confirm the list of performance tests recommended.
• Share the performance study test plan and reports of all recommended tests.
• Provide justification for tests not performed that are recommended by the USFDA.

2.10

Performance Testing_ Animal

(If applicable, rarely required for 510(k) non-active device)

• Assess the requirement of the performance animal testing.
• Provide any alternative based on device complexity to risk related to safety and efficacy.
• Send a requisition of a testing and guidance related FDA requirements to be conducted and followed.
• Review the test plan before testing (If testing has not been performed yet).
• Provide the gap assessment study in case of an existing test plan and reports if applicable.
• Prepare a detailed Performance test summary report.
• Recommend justification for non-performed test as per FDA recommendation.
• Prepare a detailed packaging description document.
• Documents the final test reports for 510(k) submission.

• Confirm the performance testing recommended.
• Share the performance study test plan and reports of all recommended tests.
• Provide justification for tests not performed that are recommended by the USFDA.

2.11

Performance Testing Clinical

(If applicable, rarely required for 510(k) non-active device)

• Assess the requirement of the performance clinical testing.
• Send a requisition of testing requirements and guidance related FDA requirements to be conducted and followed.
• Review the test plan before testing (If testing has not been performed yet).
• Provide the gap assessment study in case of an existing test plan and reports if applicable.
• Prepare a detailed Performance test summary report.
• Recommend justification for non-performed test as per FDA recommendation.
• Prepare a detailed packaging description document.
• Documents the final test reports for 510(k) submission

• Confirm the performance testing recommended.
• Share the performance study test plan and reports of all recommended tests.
• Provide justification for tests not performed that are recommended by the USFDA.

2.12

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.

3.1

CDRH Premarket Review Submission Cover Sheet (FDA Form 3514)

• Fill out 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

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.
• A comparative study between the proposed device and the predicate device is chosen.

-

4.1

510(k) Cover Letter

• Prepare and provide a template to the applicant covering all details required for the cover letter and share with the applicant instructing to use the letterhead and provide the authorized person’s signature.

• 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

MDFUSC

(FDA Form 3601)

• Create a medical device user fee cover sheet and PIN.

• Make payment to the USFDA. (Before submission of 510(k) file.)

4.4

Letter of Authorization

• Create a template and include the authorized person responsible for the submission process.

• Provide the authorization by signature and date of the person responsible for the Submission and interaction process.

5.1

Q-Submission

(Optional – Recommended before testing)

Prepare FDA-appropriate questions about the device.

• Organize the submission sections as required for a pre-submission.
• Upload documents and complete the FDA Pre-Submission template using the latest version pre-star.
• Submit the Q-Submission through the FDA CDRH Portal.
• Track FDA review progress and communicate with the FDA reviewer during the review process.

Review and confirm the questions prepared.

• Share device details and relevant test plans to support the Q-Submission.

6.1

E-STAR Preparation

• Update documents based on FDA feedback.
• Finalize all 510(k) documents and forms.
• Organize the final submission folder.
• Complete and check the e-STAR submission template to ensure all required sections are included.

Review the updated documents.

• Share updated inputs such as test reports, labeling, and risk documents.
• Approve the final submission package before it is prepared in e-STAR format.

6.2

E-STAR Submission

• Submit the completed e-STAR package through the FDA CDRH Portal.
• Confirm successful submission and share FDA confirmation with the client.

• Provide additional information if FDA requests clarification (e.g., payment or administrative issues that may cause an RTA notice).