Consultants 

We are FDA 510(k) submission consultants. We ensure the early acceptance of the 510(k) submission without RTA or AI and the successful clearance of the 510(k) submission.  We provide expert advice, predictive device analysis, product code along with regulation number identification, preparation, Identification of testing requirement and standard, US Agent service, Q-Submission and FDA review response. We carefully plan and strategize 510(k) submission to ensure early acceptance of the 510(k) submission.

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Stages of 510(k) submission

1. Initial stage (Gathering information and Gap analysis)

Description of medical device and device picture

Details of Different models (if available)

Clinical intended use

Device class and identification of relevant guidelines

Identification of predicate device

Materials of construction, CoA/MSDS of the materials

Any claims

Details of components and their purpose

The difference between different variants/models

Details of Manufacturing process

Device drawings with dimensions

Software architecture (if applicable)

Applicable test reports like performance test/Bench test, sterilization and shelf-life tests, software tests, EMC (Electromagnetic compatibility) Tests

Biocompatibility tests

Performance test in animals

Clinical trials

Device labeling

Other relevant information

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The information gathered will be reviewed against the requirement of relevant guidelines. GAP analysis will be performed to identify the missing information and develop strategies to fill the gaps.

 

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  2.  Dossier preparation and Submission

Identify Predicate Device. If there are no substantially equivalent device, follow PMA route or if substantially equivalent, follow 510(k) route

Identify Device Code and Regulation Number.

Evaluation of equivalent device (predicate) and compilation

Drafting of 510(k) file in line with available FDA guidance document

Review of Risk analysis, Equivalent device data 

Biocompatibility Test/Safety test protocols

Review of Labels, User Manual/IFU, Shelf-life records/lifetime calculation and pre-clinical study evidences

Pre 510(k) submission

Compilation of 510(k) file by incorporating the pre-submission comments

Compilation and release of the Final Draft of 510(k) file

US Agent Appointment

510(k) Fee payment and review

FDA 510(k) Submission in Hard copy and eCopy

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   3. Post submission support

Our consultants will be with you at every stage of US FDA`s 510(k) review/ clearance process starting from receipt of acknowledgement, Acceptance of review, Substantive review, Substantive interactions, interactive review, Additional Information (AI) Request, supporting the submission of responses at every stage till issue of 510(k) Decision Letter.