NEWS

FDA 510k is a review and approval process by the FDA (U.S. Food and Drug Administration) to determine the safety and effectiveness of new medical products before they are allowed to be marketed in the United States.

Compliance with the FDA 510k process is very important for manufacturers and distributors of medical products because it ensures that products allowed to be marketed in the United States meet FDA safety and effectiveness standards. Achieving FDA 510k approval also helps manufacturers and distributors of medical products assess risks and increase confidence in their products in the eyes of customers and health regulatory agencies.

In this article, we will provide you with an overview of the FDA 510k process, its importance to the healthcare industry, as well as the requirements and procedures for obtaining FDA 510k approval.

1. What is FDA 510k?

FDA 510k stands for FDA's Premarket Notification 510(k) - meaning "Pre-market Notification". The reason people use 510(k) and Premarket Notification interchangeably is that the Premarket Notification refers to section 510(k) of the Federal Food, Drug, and Cosmetic Act.

This is a submission sent to the FDA to demonstrate that the medical device being marketed is safe and effective, essentially equivalent to another legally marketed device. This means that the submitting firm must compare their medical device to one or more legally marketed similar devices, supporting claims of substantial equivalence. What is substantial equivalence in FDA 510k? Substantial equivalence here means the demonstration that a firm's new device, compared to a predicate device. A device is essentially equivalent to a predicate device if:

It has the same intended use; and

It has the same technological characteristics; or

It has the same intended use; and

It has different technological characteristics and no different safety or effectiveness issues; and

Information is submitted to the FDA to demonstrate that this new device is safe, effective as the device sold on the legal market.

The requirement for substantial equivalence does not mean that the new and predicate devices need to be identical. The FDA will initially determine that the new and predicate devices need to have the same intended use and if there are any differences in technological characteristics, there will be no significant difference in safety or effectiveness.

2. Requirements for 510k Approva

Any business that wants to market medical devices in the United States must register for FDA 510k certification at least 90 days before introducing the product to the market (except for products that were sold on the market before May 28, 1976).

To obtain FDA 510k approval, manufacturers and distributors of medical products must comply with the strict requirements of the FDA, including:

Identifying and describing the product in detail: this is the first step to ensure that your product is being properly evaluated. This includes information such as product name, function, design, materials, and technology used.

3. Submitting FDA 510(k): What You Need to Include

FDA does not regulate which objects need to submit 510(k). They regulate actions that require 510(k) submission, such as introducing, marketing medical devices in the US market.

3.1 Actions that require FDA 510k submission:

Anyone who wants to sell a medical device in the US must submit a 510(k) at least 90 days before the device is sold, unless it was marketed before May 28, 1976.

There is a change or modification to a device that is legally marketed, and the change may significantly affect the safety or effectiveness of the device.

3.2 Objects required to submit FDA 510k:

Domestic manufacturers introduce a device into the US market. Note that only finished manufacturers are required to notify before going to market. Component manufacturers are not required to do so unless they market and sell components as a replacement product.

Developers of technical characteristics introduce a device to the US market.

Repackagers or relabelers make changes to the label or perform activities that significantly affect the medical device.

Foreign manufacturers/exporters or US representatives of foreign manufacturers/exporters introduce a device into the US market.

4. When FDA 510(k) Submission Isn't Required: Understanding Your Product's Exemptions

Not all medical products need to submit an FDA 510(k). Here are some cases where medical products do not need to submit FDA 510(k):

• Sell unfinished medical devices to another company for further processing or sell components used in the assembly of devices for other companies (not sold to consumers).
• Distribute domestically manufactured devices of another company.
• Repack or relabel devices, and the label or existing condition of the device is not significantly changed.
• Medical devices that are not marketed or commercially distributed.
• Medical device products that were legally distributed before May 28, 1976, and have not been significantly changed or modified in terms of design, composition, manufacturing process, or intended use.
• Devices exempt from requesting FDA 510k certification under 21 CFR 862-892 regulations.

However, before deciding not to submit an FDA 510(k) application, medical device manufacturers should check the FDA's regulations and requirements to ensure that their products do not require this submission. If the product does not meet FDA requirements, the manufacturer will have to submit an FDA 510(k) application before the product can be sold in the US market.

In this article, we have provided you with an overview of FDA 510k and its importance in the healthcare industry. We hope that this information will help you better understand the FDA 510k process and make informed decisions regarding your medical products.

If you are looking for more detailed information or assistance in obtaining FDA 510k approval for your product, please visit our website at gol.vn. We have a team of experts with years of experience in this field ready to support you in the preparation and submission of your FDA 510k application, as well as other import and export areas.

To support Vietnamese businesses in exporting their products to the US market, GOL provides FDA-related services, including:

FDA registration services for food, cosmetics, and medical devices

Consultancy services for packaging and labeling according to FDA standards

Training and application of FSMA standards in factories (for food products)

Factory pre-audit and FDA inspection support

Representative services in the US for exporters and importers

Compliance services for FSMA regulations for importers/exporters

For more information or further consultation on FDA certification procedures and other logistic services, please contact our hotline at 0909898588 for assistance!