FDA Seeks Comments on Proposed Guidelines for Device Design and Clinical Studies

August 15, 2011—The US Food and Drug Administration (FDA) announced that it has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices. The guidance focuses on premarket approval applications (PMAs). The recommendations made in the guidance are intended to improve the predictability, consistency, and transparency of the premarket review process for applicable devices and should help manufacturers navigate the approval process more easily. The document, Design Considerations for Pivotal Clinical Investigations for Medical Devices, is available for review on the FDA's Web site.

“Clinical data is the foundation for determining the safety and effectiveness of medical devices requiring FDA premarket approval,” commented Jeffrey Shuren, MD, Director of the FDA's Center for Devices and Radiological Health. “As medical devices grow increasingly complex, many factors impact our benefit-risk determinations, especially for PMA devices. This guidance aims to provide more clarity to manufacturers about what factors we consider when making an approval decision.”

The guidance also proposes that medical-device reviewers use a worksheet to document how they make benefit-risk determinations. The agency noted that in certain cases, this document could be made public after approval, thereby increasing the transparency of the FDA's decision-making process.

In related FDA news, the agency issued draft guidance to help researchers and manufacturers design better-quality clinical studies in support of PMA applications for medical devices. The proposed guidance, Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review, is available for review on the FDA's Web site. It outlines agency expectations for clinical trial design issues such as minimizing data bias and variability, setting appropriate study objectives, selecting the appropriate type of study, and choosing study sites and study participants.

Issuing the draft guidance is one of 25 action items listed in the FDA's Plan of Action for Implementation of 510(k) and Science Recommendations that was announced earlier this year to enhance predictability and transparency of regulatory pathways and to strengthen the 510(k) process.

“We want to help manufacturers and researchers take the least-burdensome approach to getting safe and effective products to market,” stated Dr. Shuren. “This guidance will help manufacturers and researchers better understand the FDA's basic expectations for clinical trials. We encourage researchers to contact the FDA to discuss the most practical approach to studying their device.”

The FDA stated that although the evidence needed to support a PMA application varies depending on the medical device, the new draft guidance can help manufacturers and researchers design a pivotal study that is a practical investment of time, effort, and resources and has a high likelihood of demonstrating safety and effectiveness. Additionally, the recommendations of this guidance may be used in designing clinical studies used to support 510(k) submissions.

On August 17, the FDA released its Strategic Plan for Regulatory Science, which calls for a sweeping modernization of the science that is used in developing and evaluating products that come under its purview.

“The breadth and scope of the FDA's regulatory oversight is extraordinary, touching the lives of every American through the food they eat, the medicines they take, and the medical devices they use,” commented FDA Commissioner Margaret A. Hamburg, MD. “As new discoveries yield increasingly complex products, this strategic plan ensures that our experts are equipped to make science-based decisions resulting in sound regulatory policy. It positions us to foster innovation through better science without compromising our high safety standard.”

According to the FDA, the strategic plan describes the agency's intent to collaboratively enhance the process for developing and evaluating promising new products and novel materials from fields such as cell therapy, tissue engineering, genomics, personalized medicine, advanced computing, and information technology. It also underscores the agency's emphasis on food safety, as well as its intention to study and improve the way it communicates health information to consumers, particularly as communication technologies rapidly evolve and change the way people receive that information. The plan provides specific details of the agency's Regulatory Science Initiative, which was outlined in October 2010.