U.S. Medical Device Registration Requirements and Process

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Under Section 201(h) of the FD&C Act, a medical device is defined as any device, in vitro reagents, and related products that diagnose, treat, prevent, or cure a disease. Medical devices cannot achieve their purpose through chemical action or metabolism in the body. Because medical devices can directly affect human health, in order to ensure the safety and effectiveness of medical devices, the U.S. has established large, mature and complex regulatory systems.

Although registration is difficult, but once registered success, for the benefits of medical equipment manufacturers is also obvious, such as legally in the U.S. customs clearance, legally enter the world's largest medical device market, country legally registered in other approved by FDA listed products.

In this article, we detail the FDA's regulations for medical device approval in terms of registration requirements and processes, and provide some reference databases to help manufacturers register their products in a compliant manner and successfully market their medical devices in the U.S.

Determine the Medical Device Classification

FDA divides medical devices into three categories according to risk levels, and different grades of instruments with different regulatory strengths. Before preparing a premarket submission, it is essential to determine the correct classification of the medical device, both to help clarify the preparations required for the corresponding class and to estimate the overall cost and time required to bring the product to market.

Select a U.S. Agent

The FDA requires any foreign company importing a medical device into the U.S. to appoint a U.S. agent. The U.S. Agent must be a U.S. resident or have a place of business in the U.S., and is required to be available for telephone calls during normal business hours.

U.S. agent duties include:

Assisting FDA in communicating with foreign businesses
Answering questions about importing devices into the U.S.
Assisting FDA in scheduling inspections
If FDA cannot contact the foreign business directly, FDA may provide the U.S. agent with appropriate information

Choose the Right Route for Your Medical Device

Once the product classification has been determined, the correct path for premarketing submission needs to be chosen in accordance with the relevant regulations. Common types of premarket submissions include:

510 (k) (Pre-marketing notification)

A Class I or II device that has not been granted a 510(k) exemption must submit a premarket notification to the FDA, known as a 510(k). The application is to demonstrate that the device is safe and effective and that it is substantially equivalent to another device on the market.

Substantial equivalence is defined as having the same intended use and technical parameters, or having the same intended use and different technical parameters but without raising new safety or efficacy concerns. The applicant is required to submit relevant information to the FDA that demonstrates the same safety and efficacy as the marketed product.

PMA (Pre-marketing approval)

Most Class III devices require a more stringent PMA submission. The applicant must provide valid scientific evidence to prove the safety and effectiveness of the product.

De Novo (Classification request)

De Novo is a way to classify new types of medical devices that do not pose a high degree of risk. If safety and efficacy can be assured by general controls or general and specific controls alone, it can be classified as Class I or Class II.

HDE (Humanitarian device exemption)

Devices designated for humanitarian use can be submitted through the HDE pathway and are usually intended to be used to diagnose or treat rare diseases. HDE and PMA are the same in the submission of application information, but the HDE application has relatively lower requirements for product validity, faster review, and no fees.

Prepare to Submit an Application to the FDA

After determining the correct premarket submission type, you need to begin preparing your application materials.

The FDA has developed resources to assist applicants in their preparation, such as Device Advice and CDRH Learn.

To ensure a smooth application process, there are four aspects to consider when preparing for a premarket submission:

Design control

As part of the quality system, design control is to control the product development process to ensure that the product can continue to achieve its intended use. FDA stipulates that all class II and III devices need to follow the requirements of design control, and some Class I devices can be exempted.

Non-clinical testing

The operating performance and material of the device were tested in GLP laboratory, and the non-clinical test results of the product met the requirements of the corresponding category of devices.

Clinical evidence

In addition to some 510 (k) and De Novos, other applications need to submit clinical evidence to support the safety and effectiveness of the medical device product.

Label

The FDA has clear requirements for the labeling of medical devices, so applicants should ensure that the labels, brochures, user manuals and instructions of the devices are correctly marked and comply with regulations.

Submit Information

The premarket application materials are ready to be submitted to the FDA. Payment must be completed before submission for review, and the FDA charges different fees for different applications.
The exact form of submission may vary by product category. This may be an electronic eCopy (CD, DVD, or flash drive) or in paper form.
Upon receipt of the submitted premarketing application, the FDA initiates an administrative review to assess the completeness of the submitted data for substantive review.
FDA maintains contact with applicants to improve the efficiency of the review while reviewing submissions.

Complete the Registration

After obtaining the appropriate approval documents, device manufacturers must register with the FDA and list their products. The FDA requires all medical devices manufactured and distributed in the United States to register with the FDA annually and pay an annual registration fee.

Proregulations is committed to providing customized, personalized, and integrated medical device registration services to help our clients bring their products to market efficiently and in compliance. If you are interested in our services or need more details, please contact us.