Please fill out the FDA 510k request for proposal and submit it online for a comprehensive proposal. It’s crucial to realize that the precise and accurate information provided here will aid us in accurately estimating the budget.

Establishment Name *

Establishment Type *

Manufacturer
Specification Developer

A specification developer develops the specifications for a finished device, but has the device manufactured under contract by another firm or entity. The specification developer submits the 510(k), not the contract manufacturer.

Address *

Address Line 1

Address Line 2

City

State / Province / Region

Postal Code

Country

Website / URL

Role of the 510k applicant *

Role of the I3CGLOBAL *

GAP Assessment Service proposal can be generated only after submission of full 510k file.

Status of GMP *

In-House Technical Expert *

Name of the Medical Device *

Type of Device *

A specification developer develops the specifications for a finished device, but has the device manufactured under contract by another firm or entity. The specification developer submits the 510(k), not the contract manufacturer.

FDA Product Code(s)

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm

FDA Regulation Number(s)

Predicative Device 510k Number(s)

Check the database if you do not have it! https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

Device Class *

Number of Models / Variants to be covered in 510k *

Many Models / Variants ? How many ?

More Models / Variants to be included in the submission? Explain the scenario below clearly such as 1. Major Difference 2. Is any change in the intended use 3. Any change in the construction? 4. Any change in mechanism of action etc.

Intended use of the device *

What is the purpose of this Device?

Accessories Packed with a Medical Device *

Additional products supplied with the main medical device to enable, support, or facilitate its intended use.

Components Packed with a Medical Device.

Parts or elements supplied with the main medical device that form part of the device’s assembly or functionality.

Do you have an image of the device in open condition and in the final pack? If yes pls upload

Drag & Drop Files, Choose Files to Upload

Submitter Name *

Designation / Job Title *

Phone *

Email *

Customer Confidentiality Commitment

I3CGLOBAL Group protects all information our customers share with us, including technical files, product details, QMS documents, regulatory records, and business data.

When you share information with us, we commit to the following:

Confidentiality: We treat everything you share as confidential.
Limited use: We use your information only to deliver the services you have engaged us for.
Security: We use appropriate technical and organizational safeguards to protect your information from unauthorized access, loss, or misuse.
No unauthorized sharing: We never sell your information or share it without your consent. The only exceptions are when the law requires it, or when sharing it is necessary to deliver your services, for example with regulatory authorities, Notified Bodies, or authorized partners.
Your IP stays yours: All designs, processes, and documents remain your property. Sharing them with us does not transfer any ownership rights.
Need-to-know access: Only authorized staff who need your information for their work can access it, and they are bound by confidentiality obligations.
Retention and disposal: We keep your information only as long as the services or legal requirements need it, and then we securely delete or destroy it.
Bound team: Our employees, consultants, and service providers are all bound by confidentiality obligations.
Questions: You can contact us at any time with questions or concerns about how we handle your information.

Declaration
I3CGLOBAL Group takes customer confidentiality seriously and handles all information in line with our contracts and applicable data protection laws. We are also happy to sign a separate Non-Disclosure Agreement (NDA) on request. Where an NDA or data processing agreement has been signed, its terms will also apply.

Customer Confidentiality Commitment

I3CGLOBAL Group protects all information our customers share with us, including technical files, product details, QMS documents, regulatory records, and business data.

When you share information with us, we commit to the following:

Confidentiality: We treat everything you share as confidential.
Limited use: We use your information only to deliver the services you have engaged us for.
Security: We use appropriate technical and organizational safeguards to protect your information from unauthorized access, loss, or misuse.
No unauthorized sharing: We never sell your information or share it without your consent. The only exceptions are when the law requires it, or when sharing it is necessary to deliver your services, for example with regulatory authorities, Notified Bodies, or authorized partners.
Your IP stays yours: All designs, processes, and documents remain your property. Sharing them with us does not transfer any ownership rights.
Need-to-know access: Only authorized staff who need your information for their work can access it, and they are bound by confidentiality obligations.
Retention and disposal: We keep your information only as long as the services or legal requirements need it, and then we securely delete or destroy it.
Bound team: Our employees, consultants, and service providers are all bound by confidentiality obligations.
Questions: You can contact us at any time with questions or concerns about how we handle your information.

Declaration
I3CGLOBAL Group takes customer confidentiality seriously and handles all information in line with our contracts and applicable data protection laws. We are also happy to sign a separate Non-Disclosure Agreement (NDA) on request. Where an NDA or data processing agreement has been signed, its terms will also apply.

I acknowledge and understand the above detailed Customer Confidentiality Commitment.

REQUEST FOR FDA 510K PROPOSAL