I3CGLOBAL 510k Consultants help you navigate the complete process for any device class (I / II / III) of by thoroughly understanding the device and by identifying any possible pitfalls. Qualified and experienced technical experts assure faster clearance.
If you are a manufacturer or a specification developer, please read below to understand how we support customers to prepare and submit the 510(k) file faster with less chance of receiving an initial “Refuse to Accept” (RTA) hold or an “Additional Information” (AI) request from the FDA .
Core Activities of 510k Consultants.
510(k) Documentation includes but not limited to the following:
- Identify Device Class, product code and Regulation
- Appropriate Predicate device Identification
- Identify Appropriate guidance and control documents
- Choosing an appropriate type* of 510(k) submission
- Prepare Indication for Use statement
- Declaration of Conformity
- Identification of Biocompatibility tests
- Identification of Performance test
- Sampling Plan
- Requirements for stability studies
- Review of the Risk management file
- Sterilization requirements and appropriate documentation
- Labelling requirements and review of label
- 510(k) summary and predicate comparison
- Identify any clinical data/ test requirements
- Device specific documentation requirements- includes Software, EMC, and Electrical safety
- Review of Final 510(k) File
- Pre-submission (Q-submission)
- Refuse to Accept Policy for 510(k) acceptance review
- E-copy Submission
- Interact with FDA – Answering Review Comments and Additional Information requirement during the post submission phase.
- Device Listing and Registration
- US Agent Services
Advantages of appointing 510k Consultants
- Confirm the medical device require 510(k) and it regulated under FDA.
- Identification of the perfect pathway to get 510(k) clearance.
- Choosing Suitable predicate device for to establish Substantial Equivalence.
- Experienced consultants in preparing regulatory documents as per FDA requirements and previous experience with FDA submissions.
- Well-organized Documentation.
- Review of the 510(k) documentation and identify compliance gaps.
- Knowledge of latest trends and the current regulation in requirements for the submission.
- Helps in identifying appropriate performance tests, consensus standards and the requirements of other Clinical/non-clinical studies.
- Consultants can guide and give a clear recommendation in every step in the documentation, and testing on the medical device.
- Can assure the timely submission of the file.
- Interact with FDA – Answering Review Comments and if Additional Information requirement during the post submission phase.
- Support till the 510(k) clearance.
510K CONSULTING & CLEREANCE TIMELINE
While reading the FDA website, it is clear that the FDA 510k Clearance Time set by the FDA authorities is within 90 working days. The possible delay due to RTA and AI, their internal review clock stops and does not begin again until you rectify and inform the reviewer.
Our experience with the majority of medical devices’ FDA 510k clearance was obtained in 08-10 months.
A. 510k Guidance, Preparation & US Agent Service (Total Package)
Collaborate and work with client team by guiding on required outputs for the successful submission
- Reconfirm the classification, product code and regulation number.
- Select the proper predicate for your 510k submission
- Preparation of 510k
- Act as US Agent
- Electronic & hard copy submission(s)
- Answering to review comments and File re-submission.
B. 510k Review / GAP Assessment ( Without US Agent & Submission)
- Device understanding
- Review of client prepared 510k file.
C. US Agent Service submission & FDA Coordination
- Act as the US Agent
- Communication channel between the FDA and foreign facility
- E-copy and hard copy submissions to the FDA
D. US Agent Service
- Act as the US Agent