Medical Device Biocompatibility

by | Dec 7, 2020 | Biocompatibility, FDA, Gene and Cell Therapies, Quality, Regulatory, Testing

If your medical device has contact with human tissue, it is a safe bet that you will be required to conduct biocompatibility testing. Biocompatibility testing is used to determine the “potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body”.1 The FDA relies heavily on ISO 10993 as the guiding force for biocompatibility testing in medical devices. This ISO standard is rooted in a risk-based approach to testing that the FDA views as the gold standard to ensure that medical devices do not cause adverse local or systemic effects due to contact with human tissue.

Biocompatibility testing is required for almost all medical devices that have contact with human tissue. However, in alignment with ISO 10993-1:2018, you can reduce the number of tests you have to conduct if you can provide sufficient justification, including the following data:

  • Data that shows materials you are using are substantially the same as previously tested materials. If there are changes in sterilization methods, manufacturing processes, chemical composition, or patient contact, then additional testing may be required.
  • Data from suppliers of the material that have conducted their own testing
  • Clinical data from predicative devices

Before you dive into biocompatibility testing you will want to first thoroughly understand how your device interacts with the body and identify risk factors. There are several different types of biocompatibility testing, including cytotoxicity, sensitization, genotoxicity, hemocompatibility, carcinogenicity, and reproductive/developmental toxicity, just to name a few.2 Which of these tests you will have to conduct depends on the specifications and risks identified for your device.

An often-confusing nuance for biocompatibility testing is that the FDA does not have a list of approved biocompatible materials because they do not approve materials, they only approve medical devices. This is primarily because the use of a certain material in one device might not mean it will act the same in another device. Since the intended use, design, and specifications for devices can all vary, it means that it is nearly impossible for there to be a concise list of “safe” materials. The best thing for manufacturers to do is to leverage data for predicate devices that utilize the same materials in a similar way. If you have a medical device that needs biocompatibility testing, EMMA International can help! Call us at 248-987-4497 or email to get connected with our team of experts today.

1ISO (2018) ISO 10993-1:2018 Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process retrieved on 12/6/2020 from:

2FDA (2020) Use of ISO 10993-1 retrieved on 12/6/2020 from:

Madison Wheeler

Madison Wheeler

Director of Technical Operations - Ms. Wheeler serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Ms. Wheeler also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Ms. Wheeler holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

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