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.
Stages of 510(k) submission
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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
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.
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
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.