New US FDA Guidance for Medical Devices using Animal Studies
The US Food and Drug Administration has published a new draft guidance covering design and reporting processes for animal studies conducted for medical devices.
Intended for both industry and the agency’s own reviewers, the guidance pertains to animal studies submitted as part of Investigational Device Exemption (IDE) investigation applications, 510(k) premarket notification and Premarket Approval (PMA) applications and other device-related submissions. The FDA published the guidance to provide what it considers best practices for conducting animal studies.
In terms of what to information from nonclinical animal studies to include in submissions to the FDA, the guidance recommends the following materials:
- Rationale for study model(s) selected
- Similarity of selected model to clinical (human) models
- Study methodology used
- What (if any) standard operating procedures used
- Proof of quality assurance unit’s independence and impartiality concerning inspection and reporting of study data
Additional information on study groups and durations, device design iterations and outcome summaries should also be submitted with the animal study data listed above.
Manufacturers interested in soliciting FDA feedback before undertaking animal studies may request a Pre-Submission meeting in which the agency will review proposed study rationale and design. (The same Pre-Sub program is already available for IDE applicants seeking approval for clinical studies.)