FDA 510k Proposal

1. PREPARED FOR

FDA 510K APPLICANT

MANUFACTURER
SPECIFICATION DEVELOPER

Applicant Name and Full Address
(to be printed in the 510k clearance letter)

CONTACT PERSON

MANUFACTURER
SPECIFICATION DEVELOPER
CONSULTANT

2. PREPARED BY

Alsstr. 97, 41063 Mönchengladbach, Germany
Manyata NXT Towers, Bangalore, 560045, India
58, Peregrine Road, Essex, England, IG6 3SZ, UK
75 Executive Drive, 303, Aurora, Illinois-60504, USA
Fulya mah. Büyükdere No:76 Quasar, Istanbul, Turkey

NAME

CONTACT NUMBER

DATE

PROPOSAL NUMBER

I3C-510K- -R

PROPOSAL VALIDITY

3. EXECUTIVE SUMMARY
The business proposal submitted to client with full confidence in the 510k regulatory process covering technical guidance, 510k preparation, internal review, pre-submission (optional) US agent support service, answering to FDA review comments until 510k clearance. It is highly essential, responsible person from the manufacturer should coordinate with consultants throughout the process of 510k preparation, even though he/she is not directly involved in the file preparation. Technical inputs submitted by the manufacturer to the consultants for onward submission to file must be authentic and genuine. All documents /files prepared by us will be shared via DROPBOX on real-time. We assure complete data protection of customer file. We are ISO 27701:2016 Certified.

3. EXECUTIVE SUMMARY

The business proposal submitted to client with full confidence in the 510k regulatory process covering technical guidance, 510k preparation, internal review, pre-submission (optional) US agent support service, answering to FDA review comments until 510k clearance.

It is highly essential, responsible person from the manufacturer should coordinate with consultants throughout the process of 510k preparation, even though he/she is not directly involved in the file preparation. Technical inputs submitted by the manufacturer to the consultants for onward submission to file must be authentic and genuine.

All documents /files prepared by us will be shared via DROPBOX on real-time. We assure complete data protection of customer file. We are ISO 27701:2016 Certified.

4. DEVICE INFORMATION
1. Proprietary / Brand Name
Classification / Common Name
Model(s) / Variants
Product Code(s)
Device Class & Regulation Nos.
2. Proprietary / Brand Name
Classification / Common Name
Model(s) / Variants
Product Code(s)
Device Class & Regulation Nos.
3. Proprietary / Brand Name
Classification / Common Name
Model(s) / Variants
Product Code(s)
Device Class & Regulation Nos.

5. STATEMENT OF WORK (SOW)

PHASE 1- INITIAL DOCUMENTATION
DOCUMENTATION REQUIREMENTS		SCOPE OF I3CGLOBAL	SCOPE OF APPLICANT
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 DOCUMENTATION
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 DOCUMENTATION
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 signed and dated hard copy printed on business letterhead must be couriered to the US office for submission to FDA.
3.7	Truthful and Accuracy Statement	Create a template and prepare the document.	Submit document signed by the firm's contact person on the templates provided.
3.8	Declarations of conformity and Summary report	Create a template and prepare the document.	Submit document signed by the firm's contact person on the templates 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
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 extra technical inputs needed to prepare the supplementary information must be provided after thorough internal debate.
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	Post 510k Clearance	US Agent Confirmation FDA account creation Device Listing	Annual fee payment

6. PROJECT FEE

Project Fee [refer section 4 & 5] is

Discounted Fee [Agents, Associates or Multi projects] is

(In Words)

PAYMENT SCHEDULE

(Without Pre-submission)

Start of project: 40%
Before FDA Submission: 30%
Answering Initial FDA comments: 20%
After 510k clearance: 10%

(With Pre-submission)

Start of project: 40%
Before Pre-Submission: 10%
Before FDA Submission: 20%
Answering Initial FDA comments: 20%
After 510k clearance: 10%

All payments to I3CGLOBAL must be made using the tax invoices generated in accordance with the specified schedules mentioned above.

7. PROJECT TIMELINE
The abbreviated and traditional 510k preparation will take about 4-5 months on average. Pre-submission may further delay the process for 2-3 months. The FDA conducts an administrative acceptance review in 7-14 days after the file submission. The substantive review will commence in 30-60 days once the administrative review is approved. Based on our previous experience, the 510k file review and response to queries could take 6-8 months.

7. PROJECT TIMELINE

The abbreviated and traditional 510k preparation will take about 4-5 months on average.

Pre-submission may further delay the process for 2-3 months.

The FDA conducts an administrative acceptance review in 7-14 days after the file submission. The substantive review will commence in 30-60 days once the administrative review is approved.

Based on our previous experience, the 510k file review and response to queries could take 6-8 months.

8. GENERAL TERMS OF BUSINESS
8.1 NON-DISCLOSURE AGREEMENT All Confidential Information statements and information of any kind given by the applicant will be treated with the highest secrecy and confidence. Without the applicant's specific written approval, we will not divulge such Confidential Information to any third party. Directors, officers, employees, and consultants will use the Confidential Information disclosed pursuant to this Agreement solely for the Purpose, and will ensure that such persons are bound by confidentiality obligations that limit the disclosure and use of the Confidential Information as contemplated by this Agreement. 8.2 MODIFICATION. No modification, termination, or attempted waiver of this agreement, or any provision thereof, shall be valid unless in writing signed by the party against whom the same is sought to be enforced. 8.3 NO GUARANTEE. As a consulting firm, we cannot promise a positive outcome. To complete the project on successfully, we will always rely on our technical competence and previous project completion experience. 8.4 FDA REVIEW FEE. FDA 510k review fees (each file) for the present financial year $ (General) or $ (Small Business) In most cases, the FDA conducts two reviews of the payments that the consumer paid initially. If you require additional review, the same fees will apply. We shall not be participating in the decision-making process as a consulting firm. The FDA will make the final decision. To avoid such scenario, we have the option of pre-submission(refer clause 8) 8.5 NON AVAILABILITY OF TECHNICAL INFORMATION. Manufacturer and or specification developer must produce documents and records to consultants time to time as per the request and guidance. All submitted documents must be authorized by a leader for accuracy and truth. I3CGlobal team of experts are not device experts. 8.6 SURPRISE EXPENSES Additional expenses may need in case of test failures, additional testing for variants in the same device for items mentioned in clause 6. 8.7 PROJECT CONTACTS The file(s) is being handled, prepared, reviewed, and protected at Bangalore, India office, Department of Technical Documentation (FDA). The project related first line point of contact is Team Lead. The guidance and technical documentation will be taken up by technical consultants. If you feel there is an unresolved issue or a matter that requires additional attention, you should contact the Project Head who has signed clause 10 of this proposal. 8.8 NO REFUND. If a discrepancy in clause 4 is detected after project beginning, payments will not be refunded. 8.9 DELAY PENALTY (Above 120 Days). We are dedicated to complete 510k file(s) and handover to FDA / Third Parties on time. In non-delivery due to our fault, we will compensate the customer $50 each day. We expect the manufacturer to make the same commitments if not provided requested information on time, leading to delay. Both parties agree to the pay by signing the proposal below.

8. GENERAL TERMS OF BUSINESS

8.1 NON-DISCLOSURE AGREEMENT
All Confidential Information statements and information of any kind given by the applicant will be treated with the highest secrecy and confidence. Without the applicant's specific written approval, we will not divulge such Confidential Information to any third party. Directors, officers, employees, and consultants will use the Confidential Information disclosed pursuant to this Agreement solely for the Purpose, and will ensure that such persons are bound by confidentiality obligations that limit the disclosure and use of the Confidential Information as contemplated by this Agreement.
8.2 MODIFICATION.
No modification, termination, or attempted waiver of this agreement, or any provision thereof, shall be valid unless in writing signed by the party against whom the same is sought to be enforced.
8.3 NO GUARANTEE.
As a consulting firm, we cannot promise a positive outcome. To complete the project on successfully, we will always rely on our technical competence and previous project completion experience.
8.4 FDA REVIEW FEE.
FDA 510k review fees (each file) for the present financial year $ (General) or $ (Small Business)
In most cases, the FDA conducts two reviews of the payments that the consumer paid initially. If you require additional review, the same fees will apply. We shall not be participating in the decision-making process as a consulting firm. The FDA will make the final decision. To avoid such scenario, we have the option of pre-submission(refer clause 8)
8.5 NON AVAILABILITY OF TECHNICAL INFORMATION.
Manufacturer and or specification developer must produce documents and records to consultants time to time as per the request and guidance. All submitted documents must be authorized by a leader for accuracy and truth. I3CGlobal team of experts are not device experts.
8.6 SURPRISE EXPENSES
Additional expenses may need in case of test failures, additional testing for variants in the same device for items mentioned in clause 6.
8.7 PROJECT CONTACTS
The file(s) is being handled, prepared, reviewed, and protected at Bangalore, India office, Department of Technical Documentation (FDA). The project related first line point of contact is Team Lead. The guidance and technical documentation will be taken up by technical consultants. If you feel there is an unresolved issue or a matter that requires additional attention, you should contact the Project Head who has signed clause 10 of this proposal.
8.8 NO REFUND.
If a discrepancy in clause 4 is detected after project beginning, payments will not be refunded.
8.9 DELAY PENALTY (Above 120 Days).
We are dedicated to complete 510k file(s) and handover to FDA / Third Parties on time. In non-delivery due to our fault, we will compensate the customer $50 each day. We expect the manufacturer to make the same commitments if not provided requested information on time, leading to delay. Both parties agree to the pay by signing the proposal below.

9. PROPOSAL REVIEW

Name	:	Soio George
Designation	:	Project Head
Email	:	sg@i3cglobal.com
Date	:

I read, reviewed, and confirmed that the information is accurate to the best of my knowledge. I appreciate the opportunity to present our proposal to you, and I look forward to working with you.

I accept

10. PROPOSAL APPROVAL

Name	:
Designation	:
Email	:
Date	:

I acknowledge that I have read and understand the working pattern, scope of both parties, risk involved, and potential variations in project assumptions and timetables, and I now accept them. I3CGLOBAL is now requested to submit an advance payment invoice so that the project can begin as soon as possible.

I accept