The United States is one of the largest medical device markets globally. To be authorized to market medical devices in this industry, manufacturers must comply with the regulations of the Food and Drug Administration (FDA). One of the crucial regulations is the FDA 510(k) certification. So, what is FDA 510(k)? What are the regulations associated with FDA 510(k)? Let’s explore these questions with GOL in the following article!

1. What is FDA 510(k)?

FDA 510(k) is a regulation by the United States Food and Drug Administration (FDA) that mandates medical device manufacturers to submit a Premarket Notification to the FDA before introducing a product to the market. This notification must demonstrate that the new medical device is manufactured equivalently in terms of safety and effectiveness to a FDA-cleared medical device.

FDA 510(k) is a crucial regulation for medical device manufacturers aiming to bring their products to the U.S. market. The FDA 510(k) certification ensures that medical devices circulated in this market meet the standards of safety and effectiveness.

Any business intending to sell medical devices in the United States must register for FDA 510(k) at least 90 days before launching the product into the market, excluding products sold prior before May 28, 1976.

2. The substantial equivalence in FDA 510(k)

Understanding the concept of substantial equivalence in FDA 510(k) can be described as follows:

As we know, the FDA 510(k) process applies to medical devices. The fundamental requirement of this process is to demonstrate the substantial equivalence of the product to other similar medical devices already permitted to be marketed in the United States.

Substantial equivalence is understood as the new device being as safe and effective as the identified predicate device. A device is considered 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 but without issues concerning safety and effectiveness; and

• • Information is submitted to the FDA to demonstrate that the new device is safe and effective as the permitted device in the market.

The requirement for substantial equivalence does not mean that the new device and the identified device must be identical. Initially, the FDA will determine if the new and identified devices need to have equivalent intended uses, and if there are differences in technological characteristics, it does not affect safety and effectiveness.

Then, the FDA will evaluate whether the new devices meet the safety and effectiveness requirements compared to the identified devices, using scientific methods to assess differences in technological characteristics and performance data. Performance data may include both clinical and non-clinical data, encompassing technical performance tests, sterility, electromagnetic compatibility, software validation, assessment of biocompatibility, and other relevant data.

Read more: What is Premarket Approval (PMA)? – The difference between FDA (510k) and PMA

3. Regulations on Entities Submitting and Exempted from Submitting FDA 510(k)

The type of devices that determine whether an entity must submit or is exempted from submitting FDA 510(k) is not explicitly detailed by the FDA. Instead, the agency regulates actions that necessitate the submission of FDA 510(k), such as introducing or marketing medical devices in the U.S. market.

3.1 Actions Requiring FDA 510(k) Submission

There are two cases where FDA 510(k) submission is obligatory. The first case applies to any entity intending to market a medical device in the U.S. All such entities must submit FDA 510(k) at least 90 days before introducing the device to the market.

The exception is for devices commercially distributed before May 28, 1976. The second case is evident through changes or modifications made to a lawfully marketed device. However, these changes may significantly affect the safety and effectiveness of the medical device.

3.2 Entities Required to Submit FDA 510(k)

The FDA does not specify entities mandated to submit FDA 510(k). However, considering the actions, entities required to submit pre-market notification include:

• • Domestic manufacturers introducing products to the U.S. market, which need FDA 510(k) submission if the devices are finished before notification.

• • Developers of technical specifications for devices intended to be introduced to the U.S. market.

• • Repackagers or relabelers making significant changes affecting the safety and effectiveness of the medical devices supplied in the U.S. market.

• • Manufacturers or foreign exporters, or U.S. representatives of foreign manufacturers, introducing medical devices to the U.S. market.

3.3 Exemptions from FDA 510(k) Notification

Not all entities are required to submit a notification to the FDA before marketing medical devices. What are the exemptions from FDA 510(k)? The exempt entities that do not need FDA 510(k) include:

• • Suppliers of unfinished devices to another entity for further processing or sale as components for the assembly of devices by another entity, provided that the purchaser is not the end user.

• • Medical devices supplied without being marketed or commercially distributed.

• • Distributors of domestically manufactured devices from another entity.

• • Entities or facilities that repackage, relabel, or modify the existing condition of a device without making significant changes.

• • Medical devices that have been lawfully commercially distributed before May 28, 1976, with no substantial changes or modifications in design, manufacturing methods, components, or intended use.

• • Devices exempt from FDA 510(k) notification are regulated under the provisions of (21 CFR 862-892).

4. Some Considerations When Submitting FDA 510(k)

In practice, the FDA typically does not conduct pre-market inspections of manufacturing, business, and distribution facilities for medical devices before customs clearance. However, this does not diminish the importance of FDA 510(k). The submitter should and can market the medical device immediately after receiving the premarket notification license.

Manufacturers should remain in a state of readiness because the FDA may request an unexpected inspection of the FDA Quality System (21 CFR 820) after customs clearance. For foreign manufacturing companies submitting pre-market notifications, this is also worth noting.

Notifications can be sent directly to the FDA. The FDA allows foreign manufacturers to receive assistance through a legal representative in the United States and utilize contact information from a resident in the United States for convenience. Relevant information is provided during FDA registration.

5. FDA 510k Frequently Asked Questions

5.1 Do I need to inspect my facility according to Quality System regulations before submitting 510(k)?

Answer: Not necessary. FDA typically does not conduct facility inspections for 510(k) before customs clearance. However, manufacturers should be prepared for FDA Quality System (21 CFR 820) inspections at any time after product clearance. FDA may request a quality system inspection at any time, even after FDA 510(k) clearance. Therefore, even though you don’t need to inspect your facility before submitting 510(k), you should still ensure that your quality system meets FDA requirements.

5.2 Can foreign companies submit pre-market notifications for 510(k) before marketing?

Answer: Yes. Manufacturers outside the United States can directly submit 510(k) to the FDA. However, for convenience, they can receive assistance from a legal representative in the United States and use contact information from a resident in the U.S.

5.3 Is it necessary to register my facility before submitting 510(k)?

Answer: If you are a new company and do not manufacture any devices, you should not register until you start manufacturing or distributing devices within 30 days. The 510(k) submission should clearly state that you are not currently registered. However, if you have been manufacturing or distributing medical devices in the U.S., you need to register your facility before submitting 510(k).

5.4 Which reputable and quality FDA registration company should I choose?

Answer: GOL is a reputable and quality FDA registration service company that meets all the criteria mentioned. With over 20 years of experience in FDA registration for medical devices, GOL has a highly professional team with expertise in medical devices and FDA regulations. GOL has successfully assisted many clients in obtaining FDA 510(k) certification, including both domestic and international manufacturers. If you are looking for a reputable and quality FDA registration service company, GOL is a worthy consideration.

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