FDA 510 K Pre-Marketing Notification Tests

FDA (Food and Drug Administration, Food and Drug Administration), an organization affiliated to the Ministry of Health in the United States, is a legal organization that sets the rules for the delivery and use of medical supplements to consumers within the United States and publishes legal regulations. In order for any product considered as medical equipment to be placed on the market, it must pass one of the following checks:

• Pre-marketing approval (PMA, pre-market approval)
• Pre-marketing notification (PMN, pre-market notification)
• Humanitarian equipment exemption (HDE, humanitarian device exemption)

Among these, the pre-market notification process is generally known as the 510 (K) application and is frequently used by manufacturers that want to exist in this market.

In order to implement the pre-market notification process (510K), the following aspects of the equipment intended to be placed on the market must be proven:

• Medical equipment must have been on the market before 1976, or,
• It should be similar to any other equipment that has been legally authorized by the FDA to be placed on the market after this date and should be of the same purpose.

The application of FDA 510 (K) has been carried out in two different applications, special and abbreviated since 1997. For this purpose, around 1700 medical equipment have been grouped by the FDA and special legal regulations have been issued for their classification and coding. Mainly, classification was made in three basic groups: Class I, Class II and Class III. These classification methods also define the control methods that should be applied to medical equipment.

The manufacturing companies are based on the document no CFR Title 21-Part 820, which is prepared by the FDA and contains the principles of quality management system that must be followed. This document is similar to the ISO 13485 standard developed by the International Standards Organization (ISO), but has some differences in terms of documentation and implementation. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes. This standard contains the conditions necessary for the manufacturer to meet the criteria of the quality management system, which consistently meets customer requirements and legal regulations applicable to medical equipment and demonstrates the ability to provide medical equipment regularly.

In 510 (K) tests, the question of what to test is particularly important when used for a pre-marketing notification of the test report or results. The purpose of the tests is to prove that new medical equipment is equivalent to verified equipment. This equivalence has to be demonstrated for all aspects of safety and effectiveness. All clinical features and safety, material biocompatibility, environmental resistance, electromagnetic compatibility and other areas of medical equipment should be tested.

When choosing 510 (K) tests, it should be kept in the foreground to respond to all claims made for this equipment in the indications for use and in any advertising, marketing or educational material. It should also be ensured that, for each request or feature, the test equipment performs satisfactorily in the range of patients and environmental conditions. In the FDA reviews, many questions are asked within the scope of the 510 (K) statement, and the more answers to these questions, the faster the review goes.

The FDA publishes a list of national and international standards applicable to certain medical equipment, and this list is updated regularly. With the recognition of a standard, the FDA accepts testing of new equipment against all applicable parts of this standard as an alternative to comparative testing. In this case, the new medical equipment must pass all 510 (K) tests. Performing these tests according to recognized standards provides significant time and cost savings.

Within the scope of laboratory services, FDA 510 (K) pre-marketing notification testing services are also provided to the enterprises by our organization.