FDA 510k Biocompatibility Assessment

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.

What is biocompatibility testing?

A key step in the medical device biological risk assessment procedure is biocompatibility testing, which assesses how well medical devices work with the human body. This result of the test detects  the complex relationships that arise between the medical device and various living tissues and cells that it comes into contact with during patient contact.


To maximize patient benefits while simultaneously reducing biological dangers is the main goal shared by all medical device manufacturers. Reaching this fine balance requires rigorous adherence to extensive biocompatibility testing as per ISO 10993-1 required by global regulatory bodies. These strict regulations make sure that before medical gadgets are released onto the market, they are thoroughly evaluated to assure their safety.


Biocompatibility testing is essentially a basic validation method to confirm that medical devices not only meet regulatory requirements but also demonstrate the safety of the patients who rely on them.

The process of biocompatibility testing

  • 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.

Documents required for filling FDA 510k

  • Biocompatibility testing report. (Tabular detail report based on biological endpoints should be submitted)
  • Detail summary of study plan
  • Detail reports of evaluated endpoints.
  • Justification report for not conducting biocompatibility testing if biocompatibility test is not conducted.

When FDA assesses or evaluates the Biocompatablity Reports and Protocols

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.

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