U.S. Medical Device Registration with the FDA

About Us

From regulatory consulting to support getting your product approved for the market.

Our company provides comprehensive services for the approval of your medical device to enter the North American market, which include regulatory consultation, determination of classification, submission of applications, etc. We are committed to avoiding registration risk and saving time.

Medical Device and IVD Classification Determination

To guarantee effectiveness and safety, FDA classifies medical devices and IVDs (in vitro diagnostic products) into three categories based on the risk and level of regulatory control needed.

• Class I devices are in the category with the lowest risk. The applicable controls for Class I devices are subject to "general controls". Examples of this device class include bandages, oxygen masks, tongue depressors and non-electric wheelchairs. Most Class I devices do not have to obtain FDA approval or clearance but need to meet the requirements of Class I FDA product registration.
• Class II devices are in the category with medium risk. These devices are more complicated than Class I devices because they are more likely to come into sustained contact with a patient. Class II devices are subject to both "general controls" and "special controls". Examples of this device class include syringes, blood pressure cuffs, contact lenses and surgical gloves. Most Class II devices will need to prepare a 510(k) submission.
• Class III devices are in the category with the highest risk, which generally extends to permanent implants and life support systems. Examples of this device class include breast implants, pacemakers and defibrillators. Class III devices must undergo the Premarket Approval (PMA) process unless the device can be demonstrated to be "Substantially Equivalent" to an existing approved ("predicate") device. Additionally, the FDA submission includes a "Pre-submission meeting".

The classes of devices, regulatory controls and submission types are summarized in the following table:

Determine Your Device with the U.S. FDA Classification

It is important to classify your device carefully before start to prepare the correct premarket submission. There are three ways may be helpful to determine if an appropriate classification exists for your device.

• First method, in most cases, you can determine your product by the references of FDA product classification database.
• Second method, you may search for similar devices by device listing. Device listing information can be found by searching the FDA's Establishment Registration and Device Listing database using either the Quick or Advanced Search feature.
• Third method is search for similar devices. Searching for an FDA letter or order that permits market authorization, and information for a similar device type might help you determine the classification of your device. The FDA decisions that permit marketing authorization are disclosed information, and may be found by searching the following databases:

-Premarket Approval (PMA): this database includes devices with Premarket Approval, and includes the approval order, Summary of Safety and Effectiveness, and labeling for the approved devices.

-Premarket notification 510(k): this database includes releasable 510(k) information.

-De Novo: this database includes De Novo classification orders and transparency summaries.

-Humanitarian Device Exemption (HDE): this database includes devices with HDE approval, and includes the approval order, Summary of Safety and Probable Benefit, and labeling for the approved device.

513(g) Application

Device manufacturers commonly use the 513(g) request to clarify if their product falls under specific regulations, particularly the 510(k) regulations. This helps them determine whether they need to submit a 510(k) application for device modifications. Section 513(g) of the Federal Food, Drug, and Cosmetic Act allows device manufacturers to seek the FDA's guidance on the classification of their devices. By submitting a written request to the secretary, the manufacturer can receive a written reply within sixty days, detailing the device's classification and relevant regulations. To find more detail, you can read the FDA 513 (g) guidance document.

A medical device is difficult to classify since new technology and intended use, our regulatory consulting can help you to classify and determine the device in the united states, and we can process with your submission with FDA. Prepare the correct FDA submission and proper U.S. FDA classification of your device is extremely important to avoiding regulatory delays and costs, so let us help you to get your products cleared for sale into U.S. market as quickly as possible. If you need help or have a question, please feel free to contact us for more details.