Obtain and Maintain Your Medical Device Licenses in U.S. Markets.
All medical devices have to be listed with the FDA (Medical Device Listing) and all companies that will market medical devices in the US must first notify the FDA about their intention and register (Establishment Registration).
- The Food and Drug Administration Amendments Act (FDAAA) of 2007 requires that all registration and listing information (Annual, Initial or Updates) be submitted electronically unless FDA grants a waiver.
The registration of a medical device establishment is a two-step process that pay the annual registration user fee and complete the registration process. Your registration is not considered complete until you have:
Paid your annual registration user fee;
Submitted your registration and listing information electronically, and received e-mail notification from FDA that all requirements have been met.
GeBiao can help you obtain FDA clearance for your medical device. GeBiao’s team of medical device regulatory specialists provides guidance on required elements, formats, and particularities of submissions.
The FDA categorizes medical devices into one of three classes – Class I, II, or III – based on their risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness.
Class I Medical Devices: General Controls
A Class I medical device are those devices that have a low to moderate risk to the patient and/or user. About 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process. If a device falls into a generic category of exempted Class I devices, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, the manufacturer is required to register their establishment and list their generic product with FDA.
Devices on the class I exemption list include enzyme controls, tonometers, parallelometers, irrigating dental syringes, finger cots, and protective restraints for patients.
Class II Medical Devices: General Controls and Special Controls
These devices that have a moderate to high risk to the patient and/or user. 43% of medical devices fall under this category. Most medical devices are considered Class II devices.
Class III Medical Devices: General Controls and Premarket Approval
These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. They represent 10% of medical devices regulated by the FDA.
Premarket Notifications (510(k)s)
A 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 (21 CFR §807.92(a)(3)) that is not subject to premarket approval.
FDA has exempted most class I devices from 510(k) requirements, and some are even exempt from good manufacturing practice (GMP) requirements.
510(k)s take a lot of time and energy, as they require detailed scientific information and often contain hundreds of pages.
Time for FDA Approval
Although the FDA is obliged to respond to an application within 30 days, U.S. regulations regarding device development and testing in fact typically add about 3 to 6 months to obtain FDA approval to carry out clinical studies, plus 3 to 6 months for institutional review board (IRB) approval at the clinical site.
Cost of Getting a 510(k) Approved
Federal law authorizes FDA to charge a fee for medical device product review.
Please note FDA fees change annually, 510k FDA fees are over $10,000. There is a reduced fee for small businesses (businesses with gross receipts or sales of $30 million or less) of $2,899.
Also, the cost of fee is only about 1–10% of the real cost of the submission. An actual 510k costs depend on the product depending on the basic engineering and required non and clinical testing.
Make payment and obtain the Payment Identification Number (PIN) and the Payment Confirmation Number (PCN) at the Device Facility User Fee website.
For more details regarding the regulatory requirements and registration process in U.S. FDA, contract us.