Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)

While using animal-derived material in medical device manufacturing, the role of animal derived-material in medical devices is well established. However, these materials may carry a risk of transmitting infectious disease when improperly collected, stored or manufactured. The guidance describes the information you should document at the manufacturing facility and include in any premarket submissions.

So what are the considerations when using Animal-Derived Materials ?

Control of Animal Tissue Collection

• It is recommended to collect and document the following information for animal tissue-derived materials that are used as either device components (e.g., pericardium, viscera, bone, hyaluronic acid, collagen) or manufacturing reagents (e.g., tissue culture media, enzymes)
• You may document this information by reference to other regulatory submissions (e.g., Master File, PMA, 510(k)) that contain this information. 
• Maintaining records of the test results for any tests described above for each lot of material at the manufacturing facility and submitted in regulatory documents when appropriate.

Manufacturing Controls for Animal Tissue Components

• It is recommended you collect and document the information listed below for all animal-derived materials (and facilities) used in device manufacture.
• When appropriate, you should also describe these results in regulatory submissions.
• In addition, you should demonstrate and validate manufacturing equipment cleaning, decontamination, and sterilization relative to the specific pathogen exposure, and document the results.

Sterilization

• It is recommended that you consider the extent to which processing and sterilization inactivate or remove the virus.
• Recommendations for validating viral inactivation methods are described as follows:

Virus Validation Studies

• Assess the processing methods and sterilization techniques
• Obtain Viral inactivation data by determining the amount of virus in the unprocessed source material
• Determining for both before and after exposure to production and sterilization processes.
• The results should demonstrate the sum of the log clearance of virus.
• The sum must be at least six logs greater than the concentration of virus anticipated in the unprocessed source material.

Source: FDA

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