FDA 510k Certification for Medical Devices to Import and Sell in the United States

The certification of medical devices intended for the United States is the basic requirement for importation into the American market. Specifically, the 510k procedure is a notification to the FDA aimed at obtaining authorization to import and sell Class II medical devices in the USA  

The exact definition by the FDA is PMN Premarket Notification, which is distinct from PMA Premarket Authorization [this is used for Class II medical devices that do not have counterparts already on sale in the American market]

The certification of medical devices according to the 510k procedure is reserved only for Class II medical devices that have a similar device already on sale in the American market. The 510k procedure is intended to identify the similar medical device and establish functional equivalence between the similar device and the medical device to be imported into the USA.

The 510k notification is a form of FDA certification for medical devices to be exported to the American market and effectively serves as an authorization for importation into the USA.

There are two versions of 510k:

• The regular 510k certification and
• The abbreviated 510k certification.

The cost of the 510k certification varies according to the complexity of the medical device, whether it emits radiation, if it is coupled with control software, etc.

The time to obtain 510k authorization from the FDA usually varies from 3 to 9 months, and it is not uncommon for the FDA to request additional information during the medical device import approval process.

To import and sell Class II medical devices and equipment in the United States, an administrative procedure with the FDA is always required: the Premarket Authorization or the Premarket Notification [the so-called 510k]

510k Exemption

Some [few] medical machines are exempt and do not require any type of export authorization to the United States. The 510K is the most commonly required procedure by the FDA to import medical devices into the United States of America. From time to time, the 510k is defined as: import permit, registration with the FDA, FDA certification, compliance certification, authorization for importation and sale in the United States.

The 510k authorization procedure is both an import permit for medical devices into the United States and a sales authorization in America issued by the FDA

The 510k also functions as an FDA certification. It is important to note that in America the classification standards for medical devices are often very different from those in Europe.

In America, FDA classification of medical devices is on three categories:

Class I
These are the simplest medical devices and are generally exempt from any FDA authorization procedure (No premarket notification). Therefore, it is only necessary to register the establishment, appoint the so-called FDA Agent, and then also register the device with the FDA.

Class II
43% of medical devices fall into this class. Examples of Class II medical devices can also be cosmetic devices such as:

• Massagers or machines for cellulite treatment;
• Sun showers or tanning beds;
• Laser or pulsed light hair removal devices;
• Medical machinery and accessories for orthodontics such as:
• Laser fluorescence caries detector
• CAD-CAM technology machines

Class III
These are typically highly invasive medical devices where a malfunction could also pose a risk to the patient's life. 
 

WHAT IS THE FDA IMPORT APPROVAL PROCEDURE IN THE UNITED STATES 510(K)?

The Premarket Notification - commonly called 510(K) - is a simplified import permit procedure for medical devices in the United States of America.

It is based on the premise that your medical machine is similar to one already authorized by the FDA for sale in America [the so-called "predicate"]. The first crucial step, after understanding that you have a Class II machine, is therefore to identify an equivalent device.

HOW MUCH DOES IT COST TO CARRY OUT THE PROCEDURE WITH THE FDA TO OBTAIN 510K CERTIFICATION FOR THE UNITED STATES?

The FDA Device Review User Fee to proceed with the 510(K) is $5440 Update for the year 2024. If your company has an annual revenue of less than $100 million, you can register as a Small Business and save 50% on the FDA User Fee ($2509).

The entire procedure necessary to obtain the registration statistically takes 140 days on average [source: American Action Forum] and must be completed before paying the User Fee to the FDA and then being able to obtain the permit to import into the United States of America.

IMPORTING MEDICAL DEVICES INTO THE UNITED STATES: WHERE TO START?

Below we provide a checklist to facilitate the collection of documents necessary to initiate the permit/authorization procedure for importing medical devices into the United States. It should be noted that having ISO certification or other recognized quality certifications helps significantly and that all information must naturally be provided in English.

• Gather as much information as possible about the medical device.
• Provide a sheet of the equipment containing the common and commercial name of the medical device and any serial number.
• Provide a brief description of the use of the medical device. For example, whether it requires a prescription or if it is used over-the-counter.
• Indicate the competitors who already sell a medical device in the United States with technologies similar to your machine.
• Indicate whether your machine has already been authorized in other countries, for example, Europe, Japan, Canada, etc.
• Attach all relevant documents to the description of the medical device in question:
• Brief description of the product history and the technology used and how it has developed in recent years.
• Usage mode: describe the operating principle of the electromedical apparatus and the mechanism of action to achieve the intended result.
• Describe how the medical machine will be used by customers.
• Describe the production process of the medical equipment.
• Provide a list of all materials from which the device is made, including any type of metal or plastic used.
• Product accessories: provide a detailed list of all accessories and/or components used within the medical device.

Technical file: provide all the technical documentation used to construct the medical device.

Label: Provide copies of the following documents for each device or model.

Instructions for use / User manual. Includes all warnings, precautions, and contraindications. We manage this phase together with the partner law firm of ExportUSA specialized in civil liability.

• External label of the machine. 
• External label of the packaging. 
• Any brochures, flyers, and advertising material.

Sterilization and expiration date
Clarify what type of sterilization the electromedical machine undergoes. For example: if the product is supplied sterilized, not sterilized but sterilized with the end-user, or not sterilized when used. Include the chemical sterilants used, cleaning/sterilization instructions, expiration date, and storage conditions of the device.

Biocompatibility
If any component of the device is in direct or indirect contact with patients (for example, through the infusion of liquids), provide a list of device components, construction materials for these components, including any color additives. Provide any biocompatibility test results. Pay attention also to minor components, for example, the silicone with which the head of a cosmetic massager is coated. 

Software and firmware
If the medical device uses software for its operation, a description of the software must be provided along with a copy of the software user manual and any verification and validation tests of the software itself.

Electromagnetic compatibility (EMC) & electrical safety of medical machinery.
If the device requires an electrical standard (e.g., IEC), collect and attach the appropriate documentation and conformity mark. Very often, this is the case with UL certification for all electrical components and systems.

In other cases, if the medical machine emits magnetic frequencies above a certain frequency, it will be necessary to also produce the FCC [Federal Communications Commission] certification

HOW MUCH DOES IT COST TO OBTAIN 510K CERTIFICATION WITH THE FDA

This is the question that ExportUSA most often receives from our clients who want to sell medical equipment and medical devices in the United States. The answer can only be: it depends.

Let's say it ranges from a minimum of $10000-$12000 if the company intending to register 510K already has all the information cited on this page ready and possesses the ancillary certifications [for example: biocompatibility tests or software certifications that govern the functions of the medical equipment to be exported]. In this situation, it is simply a matter of correctly assembling the application and submitting the request to the FDA, but, let's be honest, it is a situation we have never encountered.

Much more common is the case where some elements necessary to present the certification request are missing and therefore need to be produced from scratch. Or some information needs to be integrated because it is incomplete. Frequently, what extends the time and increases the costs of 510K certification with the FDA are the ancillary certifications, especially those related to the control software of medical devices.

Then, if the company intending to export to America does not even have the documentation in English and all the necessary information must also be assembled, the cost increases significantly but is still linked to the complexity of the medical device to be imported.