The Centers for Devices and Radiological Health released a list of “best practices” for medical device companies performing animal studies as a precursor to human trials.
The purpose of the report, which has been in the works for some time, is to “provide a reference of best practices for the approach, conduct, and presentation of animal study data intended to demonstrate that the device under study is sufficiently safe for early human experience, while accounting for modern animal care and use strategies,” according to the document.
The objective of the guidance, “was to explain how FDA’s regulations translate to practical procedures that facilitate the expectations that our division reviewers have for preclinical studies,” Capt. Victoria Hampshire of the Office of Device Evaluation wrote in an email to MassDevice.
The procedures are open to public comment and focus specifically on companies developing intra-cardiac devices and devices used in the coronary and peripheral vasculature.
Among the recommendations made in the report include:
- Companies should follow Good Laboratory Practices (GLP) for all animal studies involving cardiovascular devices that are to be submitted to the FDA
- An animal study should demonstrate sufficient safety, including “performance and handling,” according to the report. The secondary objective should be to study the “efficacy of the device.”
A copy of the full report can be found on the agencies web site.