FDA Seeks Stakeholder Input on Animal Device Studies
The FDA has offered its initial thinking on the best practices devicemakers can adopt when conducting animal studies in preparation for a possible IDE submission.
Intended for industry and agency review staff, the draft guidance, titled General Considerations for Animal Studies for Medical Devices, is intended to guide sponsors in presenting such data for an eventual marketing application, “while incorporating modern animal care and use strategies,” the document states.
Once final, the guidance document will supersede July 2010 guidance covering animal studies for cardiovascular devices.
The document includes a section on study planning and protocol that recommends the study be planned by an individual with appropriate credentials and experience. In addition, the agency recommends an Institutional Animal Care and Use Committee review, assessing all elements of the a priori protocol that address animal care and use before study initiation or a major protocol amendment.
The document also includes a section on intraoperative monitoring to involve the observation of heart rate, electrocardiogram, blood pressure and blood gases.
Other areas covered by the document include what information is required for personnel, how to house animals and ensure their comfort, study methods and conduct and the preparation of regulatory submissions.
A Federal Register notice announcing the draft guidance’s release encourages those sponsors wishing to use an appropriate nonanimal testing to consult with the agency to determine if that method could be assessed for equivalency to an animal test method.