FDA Officials Seek Improvements in Device Feasibility Studies

FDA has been encouraging medical device sponsors to conduct more early feasibility studies (EFS) in the U.S., and it is now suggesting approaches to improving the process based on the agency’s experience with the process. Writing in a recent Journal of the American College of Cardiology article, agency officials note that in 2004 87% of clinical studies for medical technology products were conducted in the U.S. By 2009, this had dropped to 45%. “This trend has stimulated an examination of the U.S. system of clinical trials, because the integration of research into practice is a critical component of the continuum of advancement of medical care and can provide early availability of potentially beneficial devices for U.S. patients with timely regulatory approval,” they say.

The FDA authors say that “significant challenges have already been encountered that have delayed study initiation and execution: lengthy institutional review board (IRB) review, inadequate site administrative infrastructure, insufficient access to the requisite patient population, and difficulties in contract negotiations and reimbursement.” Their paper suggests approaches to improving the U.S. EFS ecosystem. For example, they say sponsors should “commit to applying the EFS guidance and process, including improved communication both prior to and during the clinical study. They can expect advantages in return via more effective and efficient future interactions with FDA, and the potential for earlier U.S. market access for their device.” FDA review teams and managers should also apply the concepts described in the EFS guidance, the authors suggest, and they should continue to develop effective approaches to a more interactive and collaborative process. “This early expenditure of time should facilitate the entire device development process,” they say, adding that adequate resources are needed for the agency to effectively perform and facilitate these activities.

The guidance discussed in the article is entitled Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies. The document says that early feasibility studies may be appropriate early in device development when clinical experience is necessary because nonclinical testing methods are not available or adequate to provide the information needed to advance the developmental process.