FDA 510k Consultants For Medical Devices
I3CGLOBAL FDA 510k Consultants help you navigate the complete process for any medical device Class I, Class II, and Class III by thoroughly understanding the device and by identifying any possible pitfalls. Qualified and experienced technical experts assure faster 510k clearance.
If you are a manufacturer or a specification developer, please read below to understand how we support customers to prepare and submit the 510k 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 FDA 510k Consultants.
FDA 510k Documentation includes but is 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 510k 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
- Labeling requirements and review of label
- 510k summary and predicate comparison
- Identify any clinical data/ test requirements
- Device-specific documentation requirements- includes Software, EMC, and Electrical safety
- Review of Final 510k File
- Pre-submission (Q-submission)
- Refuse to Accept Policy for 510k 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 Consulting
- Confirm the medical device requires 510k and is regulated under FDA.
- Identification of the perfect pathway to get 510k clearance.
- Choosing a Suitable predicate device to establish Substantial Equivalence.
- Experienced 510k consultants for preparing regulatory documents as per FDA requirements and previous experience with FDA submissions.
- Well-organized Documentation.
- Review of the 510k documentation and identify compliance gaps.
- Knowledge of the 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.
- 510k 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 510k clearance.
FDA 510k CONSULTING & CLEARANCE 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 510(k) clearance was obtained in 08-10 months.
A. 510(k) 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 510(k) submission
- Preparation of 510(k)
- 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
- The 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
510k CONSULTING STAGES