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The FDA, the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to general considerations for animal studies involving medical devices.

The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance thereto.

At the same time, provisions of the guidance are non-binding in tier legal nature, nor are they intended to introduce new rules or impose new obligations.

Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legal framework and has been agreed with the authority in advance.

Testing Facility Selection

The scope of the guidance covers, inter alia, the aspects related to the facility selection.

According to the document, the outcome of animal studies can be greatly influenced by the choice of testing facilities.

Thus, it is vitally important for the sponsor to ensure that the facility engaged adheres to regulations concerning the housing, care, and transportation of research animals.

The FDA advises sponsors to refer to published guidelines that focus on the well-being of research animals to reduce experimental confounding factors.

These guidelines outline minimum housing standards, husbandry, social and environmental enrichment, and procedures for veterinary care.

Moreover, the authority further emphasizes that the complexity of the animal study design should be a consideration in facility selection.

Complex studies may require facilities and staffing similar to those in human clinical settings to ensure high-quality results.

Facilities should be equipped with appropriate equipment and supplies, and staff should be well-trained, including in the use of the medical device under study.

Advanced imaging, intensive care procedures, and sophisticated post-procedural monitoring, akin to intensive care unit levels, may be necessary.

The FDA does not license or certify testing facilities for compliance with GLP Regulations.

Facilities conducting GLP animal studies must comply with 21 CFR Part 58 and other relevant requirements, including allowing FDA inspections.

Animal Housing

Adequate enclosure space is required to segregate different species, quarantined animals, and test systems.

If procedures necessitate intensive care during specific periods, facilities should provide recovery rooms or enclosures for individual monitoring and treatment.

Group housing of social animals is recommended to reduce stress, but environmental conditions should not interfere with study assessments.

Monitoring for bullying and ensuring equal access to resources like food, water, and enrichment devices is essential.

The FDA emphasizes the importance of play and exercise for animal well-being.

Animal Quarantine and Conditioning

Quarantine and stabilization periods before study enrollment are vital to exclude animals with diseases or conditions that might impact the study.

Minimizing background disease levels is important to avoid data distortion. Stress from surgery or dense housing can exacerbate sub-clinical infections.

Socialization programs are recommended to reduce stress and potential confounding factors.

Food, Water, and Basic Husbandry

Facilities must have standard operating procedures for housing, feeding, handling, and caring for animals.

If feed and water contaminants could affect study results, protocols should specify limits and testing methods.

For large animals in chronic studies, nutritional needs must be met even in agricultural settings.

Routine health checks, including parasite checks and body condition scoring, are suggested to prevent health issues from affecting study outcomes.

Records and Reports

A final study report, prepared by the study director, is mandatory. Amendments to the report must also be documented.

The FDA recommends including raw data, case report forms, medical records, pathology reports, and images as secondary attachments to the final report. Justification for the animal model, including scientific evidence and a review of any limitations, should be provided.

The report must detail storage locations for all specimens, raw data, and reports. Dating all study observations is advised for accurate event capture and assessment of differences between subjects.

All data, documents, protocols, reports, and specimens generated from the study must be retained, and the FDA may request additional raw data during the premarket review process based on reported study results.

Conclusion

In summary, the present FDA guidance provides additional clarifications and recommendations with respect to certain specific aspects associated with animal studies involving medical devices.

The authority further emphasizes the importance of following these recommendations in order to ensure the accuracy and reliability of the data collected.

Source

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-considerations-animal-studies-intended-evaluate-medical-devices

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