Join the Experts for your 510k FDA Clearance
We have 25 years of experience with U.S. and International 510k FDA clearance of medical devices. Join our team and we will achieve the 510k FDA clearance that is required for the U.S. market. We have cleared a variety of devices such as dental sensors, x-ray devices, orthopedic fixators, dental resins, implants and abutments, ophthalmic slit-lamp and fundus camera and the first FDA clearance for a 3-D printed dental resin.
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Services Provided by 510k FDA Consulting
- Evaluate the classification of your medical device.
- Determine the proper FDA product code and regulation number.
- GAP analysis of your device documentation.
- Select the proper predicate for your 510k submission.
- Review testing requirements for your device.
- Provide you with a detailed product-specific list of necessary documents required.
- Collect the data and documentation needed and prepare the 21 sections of the 510k submission.
- Coordinate the payment of your FDA review fee on your behalf.
- Complete the 510k Submission Package and ship to FDA.
- Answer any and all follow-up questions for the FDA reviewer.
- Prompt responses to your questions and we keep you updated during the review.
Get your 510k process started.
Top 10 List for Getting Started with your 510k
- Determine the need for Premarket Submission 510k.
- Client signs 510k FDA Consulting Contract.
- Assist Client with Application for Small Business Certification, if applicable.
- Client will receive a Checklist of the information/data needed for the 510k submission.
- Consultant will evaluate the new medical device and determine the product code, regulation number, classification and predicate device to be used for the submission.
- Client will send files of documents to 510k FDA Consulting for the preparation and writing.
- All 21 sections of the submission will be completed and formatted per FDA regulations by the consultant.
- Submission will be sent to FDA.
- FDA completes a preliminary review and then submission moves into the substantive review and the FDA clock begins.
- 510k FDA Consulting follows through the process with the FDA reviewer to complete and obtain clearance of the new medical device.