An Overview of 510k Submission

Upon device identification for 510k submission, you must appoint consulting company building evidence of substantial equivalence, device safety, and performance is recorded, The consultant expertise is a must to develop a 510k submission that best reflects your unique device and all your development efforts.

THE US Agent and consultant can also represent your company to USFDA as the official correspondent for the submission of medical devices for any class of device. The service of the US Agent can be helpful in coordinating on formal review inquiries in the submitted documents.

A legal manufacturer only can submit 510k submission to USFDA other than specification developer. The legal manufacturer will determine the documentation required for device design, risk analysis, performance requirements, and verification of these reports. The legal manufacturer will also determine device and process validations, as well as design transfer requirements in case of 510k clearance delayed.

I 3 CONSULTING  during the device development stage can be extremely helpful as our team support for 21 CFR 820 / 62304 can be very useful.  The system is the back born of any FDA 510k submission process. No matter whatever the device is. This requires completed device documentation such as inputs, device specifications, risk analyses, verification protocols with acceptance criteria that align with inputs, and verification test results that demonstrate that the criteria have been met.  I 3 Consulting can be much helpful in the 510k submission process and US Agent Service.