The Advanced Medical Technology Association (AdvaMed) is calling on the US Food and Drug Administration (FDA) to clarify aspects of a recent draft guidance intended to set expectations for animal studies for medical devices.

Draft Guidance

FDA released the draft guidance, General Considerations for Animal Studies, for public comment in October 2015. The guidance is intended to assist industry in designing, conducting and reporting data from animal studies used to demonstrate device safety.

The guidance recommends sponsors adhere to the three Rs: reduction, replacement and refinement and other regulatory principles to use the fewest number of animals to get scientifically valid results.

The guidance also notes that FDA "is available to review [the] rationale for and design of an animal study as part of a Pre-Submission."

Industry Comments

In comments submitted to the public docket, industry group AdvaMed says FDA needs to clarify what types of studies the guidance covers, and when companies need to submit raw data from the studies to FDA.

In the scope statement of the guidance, FDA writes "this guidance is intended specifically to apply to in vivo nonclinical laboratory studies as defined in 21 CFR 58.3(d)." However, the definition in 21 CFR 58.3(d) applies specifically to studies used to determine safety, and excludes field trials in animals.

But, as AdvaMed points out, the guidance also mentions device performance and efficacy in relation to the studies, which the group says are often "conducted in compliance with requirements stated in 21 CFR Part 820 [Quality System Regulation (QSR)]," rather than under 21 CFR Part 58 [Good Laboratory Practice (GLP)].

In separate comments filed by Johnson & Johnson, the company calls non-GLP studies conducted under the QSR "an equally important mechanism for generating valid scientific evidence."

AdvaMed also asks FDA to clarify when the agency wants to see raw data from animal studies. Under 21 CFR Part 58, sponsors are required to include the location where raw data is stored in their final report, but does not require the raw data to be included.

However, the draft guidance says sponsors "should provide an attachment to each final study report for each animal study that includes study details, including signed and dated individual scientific reports (e.g., the study director, the clinical veterinarian, the pathologist, and the radiologist), accompanying test protocols, and raw data," and includes raw data in a sample final study report.

PETA Comments

The animal rights group People for the Ethical Treatment of Animal (PETA) also commented on FDA's draft guidance, urging the agency to add language to the guidance to inform companies on how to get feedback on using non-animal studies instead of animal studies.

While FDA references guidelines from other agencies and bodies in its draft guidance, PETA also requests the agency add a specific appendix listing alternatives to animal testing validated by the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM), the US Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the Organization for Economic Co-operation and Development (OECD).

Public Docket