The 510 (K) implementation is included in regulation 21 CFR 807 issued by the FDA. Within the scope of this agreement, the information must be presented in a regular and tabular document.
The purpose of the 510(K) product compliance tests designed by the FDA (US Food and Drug Administration) is to provide sufficient detail to determine that a medical device is largely equivalent to other legally marketed equipment.
For any device, 510(K) has the same format and contains the same basic information. Generally, compatibility testing of FDA 510k Consultants products in a traditional, specialty, or shortened format is required.
To obtain the marketing permit, the manufacturer must prepare a complete application and perform the required 510K tests. To simplify FDA review of application data, analysis, and results, the manufacturer must perform the following verifications:
- Logical presentation of the data.
- Scientific robustness and test data analysis.
- Suitability of the test program for medical equipment and intended use
- Complete summary report of tests or studies.
In the 510K application, the details and explanations of the tests and results are very important. All processes and test results must be submitted to the FDA in reasonable and sufficient detail.
This presentation should include properties, photographs and similar documents, clinical test performance data, sterilization information, and equipment-specific protective documents, including classification, identification, final draft labeling, equipment engineering drawings.
Briefly, the 510 (K) tests cover various analytical studies to show that a new medical device is equivalent to another commercially available medical device.
These studies aim to determine that the new device is as safe and effective as the existing device. Usually, this statement means that the new device is made from the same materials as the existing device and is similar in 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-market approval process (PMA, pre-market approval), followed by more detailed and regulatory testing. (pre-market notification, PMN, pre-commercialization). notification). This second process means 510 (K) product suitability testing.
A wide variety of advanced laboratory analytical solutions are provided to help determine product equivalency to support the 510 (K) process. Various analytical testing services provided within this scope are
:
- Chemical characterization
- Material compatibility
- Biocompatibility (according to ISO 10993)
- Removable and sealed
- Definitions of impurities
- 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 the identification of MDR CE Marking materials, the determination of the presence of impurities and deterioration, or the creation of the chemical profile of an unknown formulation.
Material compatibility is the investigation of whether the different components of a medical device will negatively interact with each other and whether it affects the overall performance and safety of the device.
Medical devices are becoming more complex and more materials are being used, increasing the potential for negative interactions. Before testing the efficacy and performance of a medical device, it is important to test the interaction between the components of the material.
Material compatibility studies must be conducted as part of the premarket notification request and 510 (K) testing.
Biocompatibility, on the other hand, means that the materials that make up a medical device intended to come into contact with the human body do not hurt human health.
Within the scope of laboratory services, our organization also provides 510K product conformance testing services.
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