FDA Issues Draft Guidance on Medical Device Clinical Trials

FDA clinical trial medical device

FDA Seeks Comment on Draft Guidance Document

FDA has issued two new draft guidance documents on medical device clinical trials to support a Pre-Market Approval application (PMA). Approximately 30% of FDA regulated clinical trials are for medical devices and are regulated by the IDE regulations (21 CFR 812). The remaining 70% are for drugs and biologics and are regulated by the IND regulations (21 CFR 312). The majority of guidance documents, including ICH E6 for good clinical practice, and the majority of clinical trial vendors address drug products, not medical devices. Although Good Clinical Practice is relevant to all clinical trials there are unique aspects for device studies as opposed to drug studies. This is one reason that FDA issued a device-specific guidance document.

The draft guidance document, Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff – Design Considerations for Pivotal Clinical Investigations for Medical Devices (August 15, 2011), addresses therapeutic and aesthetic devices and diagnostic devices. Areas the document address include; Regulatory Framework for Level of Evidence and Study Design, The Importance of Exploratory Studies in Pivotal Study Design, Clinical Outcome Studies, Diagnostic Clinical Performance Studies, and Sustaining the Level of Evidence of Clinical Studies. The guidance states that its scope is:

clinical trials FDA medical device

Design Considerations for Pivotal Studies

“This guidance describes principles that should be followed for the design of premarket clinical studies1 that are pivotal in establishing the safety and effectiveness of a medical device. Practical issues and pitfalls in pivotal clinical study design are discussed, along with their effects on the conclusions that can be drawn from the studies concerning safety and effectiveness.”

The Agency also released the draft guidance document; Draft Guidance for Industry and Food and Drug Administration Staff – Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review (August 15, 2011). The Agency states:

FDA clinical trial medical device

Benefit-Risk Determination

“This guidance document explains the factors that FDA considers when making benefit-risk determinations in the premarket review of certain medical devices. The processes discussed in this guidance are applicable to devices subject to premarket approval (PMA) applications and, in limited cases, devices subject to premarket notification (510(k)) requirements. This guidance applies to both diagnostic devices and therapeutic devices.

Although guidance is not binding, the concepts and factors described herein generally capture how benefit-risk determinations are made by FDA during the premarket review process.”

Read the Guidance Document on Design Considerations

Read the Guidance Document on Benefit/Risk Determinations


ALSO of interest: FDA is currently accepting comments on the IVD Draft Guidance Document on In Vitro Companion Diagnostic Devices.

The draft guidance was issued 14 July, Bastille Day. I wish that I could explain it to you as well as Jamie K. Wolszon at the FDA Law Blog, but I can’t so I recommend taking a look over there:


FDA Law Blog on IVD Companion Devices


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