FDA 510k Biocompatibility Assessment

Device biocompatibility is the ability of a medical device or material to perform with an appropriate host response in a specific application. The purpose of performing biocompatibility testing is to determine the fitness of a device for human use, and to see whether use of the device can have any potentially harmful physiological effects. The FDA assesses the biocompatibility of the whole device and not just the component materials. ISO 10993-1, Biological evaluation of medical devices is an international standard that has to be followed by every sponsor while evaluation and testing within a risk management process.

The biocompatibility of a device depends on several factors, including:

• The chemical and physical nature of its component materials.
• The types of patient tissue that will be exposed to the device.
• The duration of that exposure.

An integral part of biological risk assessment, biocompatibility testing assesses the compatibility of medical devices with a biological system. It studies the interaction between the device and the various types of living tissues and cells that are exposed to the device when it comes into contact with patients.

The goal for all medical device manufacturers is to provide maximized benefits to patients while minimizing levels of biological risks. This requires them to comply with stringent biocompatibility testing requirements set by international regulatory bodies to ensure that their devices are medically safe to use before being made available in the market.

• Develop a Biological Evaluation Plan (BEP).

This reviews device and its materials, identifies all potential risks, and suggests possible evaluations or testing to address those risks. The BEP serve as initial risk assessment, and this information can be shared with the FDA during free pre-submission discussion. This helps to find out if the FDA might require anything further that haven’t included.

• Device evaluation and testing.

This involves the tests identified in BEP. Usually, this includes combination of in vivo or in vitro biological tests, chemistry tests and toxicological risk assessment, written assessment based upon scientific literature. List of tests below:

• Cytotoxicity
• Sensitization
• Irritation of intra-cutaneous reactivity
• Acute systemic toxicity
• Material-Mediated Pyrogenicity
• Subacute/Sub chronic toxicity
• Genotoxicity
• Implantation
• Hemocompatibility
• Chronic toxicity
• Carcinogenicity
• Reproductive/Developmental toxicity
• Degradation
• Produce a Biological Evaluation Report (BER).

In these results of all tests and evaluations are summarized. This is submitted to the FDA along with test results.

Medical devices that come in contact with body directly or indirectly are evaluated for the potential unacceptable adverse biological response resulting from contact of the component materials of the device with the body.

For example, masks or gloves intended for protective purposes by clinical practitioners so they should be assessed for biocompatibility. Similarly, majority type of non active devices should be assessed for biocompatibility.