510K Product Compliance Tests

Protective Clothing Tests

510K Product Compliance Tests

The 510 (K) implementation is included in the 21 CFR 807 regulation issued by the FDA. Within the scope of this arrangement, the information should be presented in a regular and tabular document. The purpose of the 510 (K) product compliance tests designed by the FDA (U.S. Food and Drug Administration) is to provide sufficient detail to determine that a medical equipment is largely equivalent to another legally marketed equipment. For any device, 510 (K) is essentially formatted the same and contains the same basic information. In general, 510K product compatibility tests are required in traditional, special or shortened format.

510K Product Compliance Tests

In order to obtain marketing permission, the manufacturer must prepare a complete application and have the required 510K tests done. In order to simplify the review of the data, analysis and results of the application by the FDA, the following checks should be made by the manufacturer:

  • Logical presentation of the data
  • Scientific robustness and data analysis of the test
  • Suitability of the test program to medical equipment and intended use
  • Complete summary report of tests or studies

In the 510K application, the details and explanations of the tests and the results are very important. All test processes and results must be submitted to the FDA with reasonable and sufficient details. In this presentation, properties, photographs and similar documents, clinical test performance data, sterilization information and equipment-specific protective documents must be included, including classification, identification, final draft labeling, engineering drawings of equipment.

Briefly, 510 (K) tests cover various analytical studies to prove that a new medical device is equivalent to another commercially available medical device. These studies are aimed at determining that the new device is as safe and effective as the existing device. Typically this statement means that the new device is made of the same materials as the existing device and has a similar design to this device. If the new device is significantly different from the existing device or if new materials are used in its production, the manufacturer will first go through a pre-marketing approval (PMA, pre-market approval) process, followed by more detailed and regulatory tests (pre-marketing notification, PMN, pre-market). notification). This second process means 510 (K) product suitability tests.

A wide variety of analytical solutions are provided in advanced laboratories to help determine product equivalence to support the 510 (K) process. Various analytical testing services provided within this scope are:

  • Chemical characterization
  • Material compatibility
  • Biocompatibility (in accordance with ISO 10993 standard)
  • Removable and sealed
  • Impurity definitions
  • Method development
  • Method validity
  • Failure analysis
  • Mandatory tests

For example, chemical characterization is the process of defining the chemical properties of one or more components of a substance or material used in the manufacture of the device. Characterization methods are applied for reasons such as identifying materials, determining the presence of impurities and deteriorations, or creating the chemical profile of an unknown formulation.

Material compatibility is the investigation of whether different component materials in a medical device will interact negatively with each other and whether it affects the overall performance and safety of the device. Medical devices are getting more and more complex and more materials are used, which increases the potential for negative interactions. Before testing the efficacy and performance of a medical device, it is important to test the interaction between material components. Material compatibility studies must be done as part of pre-market notification application and 510 (K) tests.

Biocompatibility, on the other hand, means that the materials that make up a medical device intended to come into contact with the human body have no negative impact on human health.

Within the scope of laboratory services, 510K product conformity testing services are also provided by our organization.

Get Offer Now

To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.

Whatsapp