Companies (establishments) that are involved in the production and distribution of medical devices intended for use in the United States, are required to register and list their products with the U.S. Food and Drug Administration, then renew their registration between October 1 and December 31, each year.
Bringing a device to the market in the U.S. may appear complex. The following steps may assist you to navigate the process.
■ The first step in preparing a device for marketing in the United States is to determine how the FDA has classified your device. Medical devices are categorized into one of three classes (I, II, or III), based on the degree of risk they present.
■ Select and prepare the correct premarket submission: Premarket Notification (510(k), De Novo Classification Request, Exempt, Premarket Approval (PMA), Product Development Protocol (PDP), Humanitarian Use Exemption (HDE), and Biologics License Application (BLA).
■ Prepare the appropriate information for the premarket submission.
■ Comply with applicable regulatory controls, including Establishment Registration and Device Listing.
ITB HOLDINGS LLC provides the following services to domestic and foreign companies that are manufacturers, exporters, importers, or distributors:
■ Medical Device Establishment Registration
■ Medical Device Listing
■ U.S. Agent Service (Foreign Companies)
■ Premarket Notification 510(k)
Once your company becomes a client, we help you setup and pay FDA’s User Fees, then list your medical devices.
All establishments that are required to register must pay an annual registration user fee.
$5,236.00 | Establishment Registration, (FY 2020 – October 1, 2019 through September 30, 2020)
The establishment registration fee is not eligible for a reduced small business fee.
$2,899.00 | Premarket Notification 510(k), single payment
Small Business Fee | (FY 2020 – October 1, 2019 through September 30, 2020).
Devices exempt from Premarket Notification 510(k) dot not incur this fee.
Diagnostic tests, ventilators, and personal protective equipment (PPE) – including surgical masks, face shields, respirators, gowns, and gloves – are regulated as medical devices.
Therefore, contact ITB HOLDINGS LLC before exporting or importing these products.
Class I and Class II Devices Exempt from Premarket Notification 510 (k)
Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.
The Manufacturer and User Facility Device Experience (MAUDE) database houses MDRs submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters including health care professionals, patients and consumers.
However, there are some limitations: potential submission of incomplete, inaccurate, untimely, unverified, or biased data.