What the law requires: As a Domestic (in the U.S.) or Foreign (outside the U.S.) Food, Beverage, Medical Device or Drug Facility, you have to:
- Register with the United States Food and Drug Administration (the "FDA");
- Appoint a Qualified U.S. Agent if you are a Foreign Food, Beverage, Medical Device or Drug Facility; and
- Notify the FDA of any changes of your information.
- Foreign Medical Device FDA Registration and US Agent Service: USD 450.00 per year
- Product Registration (listing) exempt of 510(k): USD 50 per product (usually Class I)
- 510(k) process with our exclusive 510kOnline platform: USD 2,200.00 per submission (stand alone product or bundle, if appropriate), no monthly fees, no time limit.
- UDI: get a quote for your UDI submission to FDA. Contact us.
**US Government fees are paid directly to the FDA (Docxpresso assist you to create your account and guide you with all necessary information on documentation to pay your fees directly to FDA)
- Foreign Food Facility FDA Registration and US Agent Service: USD 350.00 per year
- Prior Notice: USD 25 per shipping
- Label Review: USD 1,100.00 per label (recommended)
WHAT IS A 510(k) SUBMISSION
FDA 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA). 510(k) Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate."
FDA 510(k) submissions for medical devices are reviewed and processed by the Center for Devices and Radiological Health (CDRH) within the Food and Drug Administration (FDA). Until the submitter receives an order declaring a device SE (substantially equivalent), the submitter may not proceed to market the device. Once the device is determined to be SE, it can then be marketed in the U.S. The SE determination is usually made within 90 days and is made based on the information submitted by the submitter. FDA 510(k) is not FDA approval or FDA certification of the medical device, it is only a marketing clearance. FDA does not provide approval or certification through 510 k process nor issue a certificate of registration, but you will get a 510 k number.
Please note that FDA does not perform 510(k) pre-clearance facility inspections. The submitter may market the device immediately after FDA 510(k) clearance is granted. The manufacturer should be prepared for an FDA quality system (QSR) inspection at any time after FDA 510(k) clearance.
All manufacturers (including specification developers) of Class II and III devices and select Class I devices are required to follow design controls during the development of their device. The holder of a 510(k) must have design control documentation available for FDA review during a site inspection. In addition, any changes to the device specifications or manufacturing processes must be made in accordance with the Quality System regulation (QSR) and may be subject to a new 510(k).
DOCXPRESSO can assist you to get FDA 510(K) Clearance (Approval) for your medical device; our experienced consultants can provide you the right guidance in FDA 510 k submission requirements. Our consultants can help you from predicate device selection through establishment registration and listing. DOCXPRESSO provides US Agent service for foreign medical device manufacturers.
Our services includes:
- Identification of device class, product code and regulation number
- Identification of predicate device
- Identification of test standards
- Identification of 510k test requirements
- Identification testing or certification lab
- medical device label review
- Preparation of 510k documents through our 510kOnline platform
- Submission of 510k documents to FDA
- Provide US Agent service for 510 k
- Communicate to FDA on behalf of our client
- Review your clarifications to questions from FDA
- Assistance in transfer of 510k review fees to FDA
- Notify the new 510 k number
- Assistance in Establishment registration with FDA
- Assistance in Device Listing with FDA
Sections included in FDA 510(K) submission in our exclusive http://www.510kOnline.com
Please note there is no 510(k) form.
- FDA Medical Device User Fee Cover Sheet
- FDA Premarket Review Submission Cover Sheet
- FDA 510(k) Cover Letter
- FDA 510(k) Indications for Use Statement
- FDA 510(k) Summary
- FDA Truthful and Accuracy Statement
- FDA Class III Summary and Certification
- Financial Certification or Disclosure Statement
- Declarations of FDA Conformity and Summary Reports
- FDA 510 (k) Executive Summary
- Medical Device Description
- FDA 510(k) Substantial Equivalence Discussion
- Proposed Labeling
- Sterilization and Shelf Life
- Electromagnetic Compatibility and Electrical Safety
- Performance Testing - Bench
- Performance Testing - Animal
- Performance Testing - Clinical