The 510(k) Premarket Notification program is a relatively inexpensive pathway for companies to obtain regulatory clearance to introduce “me, too” medical products in the American marketplace.
A firm’s biggest expense typically is for any applicable third-party testing for electrical safety, biocompatibility, and sterilization. These tests, though, are required to enter any of the major global markets (U.S., Europe, Canada, Japan, Korea, China, Brazil, and so forth); and once performed, they can be used for regulatory clearance in any of those markets. So if you already paid for these tests for another market, they can be used again for an FDA 510(k) petition.
All medical devices also typically undergo performance testing, either comparison to consensus standards or direct bench testing against a predicate (competitor), and, if applicable, verification and validation testing of software/firmware. Both performance and software testing are done in-house by the manufacturer.
The good news is the FDA must clear your device if you show substantial equivalence to at least one legally marketed competitor, or “predicate,” device.
Our consulting fees are fixed, unlike other firms which charge by the hour!
A list of FDA Fees follows…
- Device Review User Fee – $4,690 … This is the Federal filing fee that FDA charges to review the 510(k).1
- Establishment Registration Fee – $3,382… Annual FDA charge for your company registration; however, if your firm has already registered with the Agency, there is no additional charge to add a new medical device. Establishments required to register with FDA include all domestic or foreign firms that manufacture, repackage, relabel, or initially import a medical device for distribution in the United States.
- Device Listing – No charge by FDA.
- U.S. FDA 510k Agent Designation –No charge by FDA
1: There is an FDA application for small business (less than $100,000,000 in annual sales) which FDA takes 60 days to review, that can qualify you for a discount review fee of $2,614. Before filing your 510(k) petition, you will need to have proper documentation confirming your business status as a small or large scale business. This paperwork is usually issued by the IRS or a sending country’s governing tax authority.