US FDA 510K Request Proposal

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 *

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 *

Intended use of the device *

What is the purpose of this Device?

Device Brand / Trade Name

Number of Models to be covered in 510k *

Major Difference between the Models *

Any Accessories included (packed/sold along with Device) *

Submitter Name *

Designation / Job Title *

Phone *

Email *

REQUEST FOR FDA 510K PROPOSAL