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.
FDA conducts inspections of medical device manufacturers to ensure they comply with the safety and effectiveness regulations. Warning Letters are FDA’s principal means of achieving prompt voluntary compliance. FDA will take steps to refuse entry of medical devices into the United States, with detention without physical examination (DWPE), until violations are addressed.
The Food and Drug Administration has the authority to ban a medical device intended for human use if it finds, on the basis of all available data and information, that the device presents a substantial deception to patients or users about the benefits of the device, or an unreasonable and substantial risk of illness or injury, which cannot be corrected by a change in the labeling.
Bringing a device to the market in the U.S. may appear complex. The following steps may assist you in navigating 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.
▪ Secondly, 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).
▪ Then, prepare the appropriate information for the premarket submission.
▪ Finally, comply with applicable regulatory controls, including Establishment Registration and Device Listing.
Before listing of medical devices takes place, the establishment must first register with the U.S. Food and Drug Administration.
When you seek and request the assistance of an FDA Consultant or U.S. Agent such as ITB HOLDINGS LLC, a Service Fee will be due.
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.
- Company Registration
- Product Listing
- U.S. Agent Service
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.
Selling medical devices on Amazon or other online platforms?
All establishments that are required to register, must also pay User Fees to the U.S. Treasury.
Establishment Registration: $6,493.
Premarket Notification 510(k): $4,967 (with Small Business Certification).
Additional fees may apply.
Devices exempt from Premarket Notification 510(k) dot not incur the fee above.
Class I and Class II Devices Exempt from Premarket Notification 510 (k)
CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
HEMATOLOGY AND PATHOLOGY DEVICES
IMMUNOLOGY AND MICROBIOLOGY DEVICES
EAR, NOSE, AND THROAT DEVICES
GENERAL AND PLASTIC SURGERY DEVICES
GENERAL HOSPITAL AND PERSONAL USE DEVICES
OBSTETRICAL AND GYNECOLOGICAL DEVICES
PHYSICAL MEDICINE DEVICES
Medical Device Establishment registration and listing are still required for these devices.
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), as well as voluntary reporters including health care professionals, patients and consumers.
However, there are some limitations: potential submission of incomplete, inaccurate, untimely, unverified, or biased data.