NEW YORK (GenomeWeb News) – The US Food and Drug Administration has released a draft document that proposes guidelines for the design of clinical studies in support of submissions to the agency for high-risk medical devices including some diagnostic tests.
FDA also has begun taking public comments on the guidance – "Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff - Design Considerations for Pivotal Clinical Investigations for Medical Devices" – which is aimed at researchers and manufacturers working on studies to support submissions for premarket approval.
PMA submissions include data from pivotal clinical studies that FDA uses to assess a medical device and to determine whether it will be approved.
This proposed guideline covers the agency's expectations for issues that affect clinical trial design, such as how to minimize data bias and variability, how to set appropriate study objectives, select appropriate types of study, and choose where studies will be sited and who will participate.
Although the evidence required to support PMA applications varies depending on the medical device, this guidance is aimed at helping 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," FDA said in a statement. These guidelines also could be applied to 510(k) applications, the agency added.
“We want to help manufacturers and researchers take the least burdensome approach to getting safe and effective products to market," said Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health. “This guidance will help manufacturers and researchers better understand the FDA’s basic expectations for clinical trials."
Included in the guidance is information about how developers of medical devices should assess the risk and benefit of their devices. Criteria for such an assessment should account for "diversity in the target population that may use or be tested with the device;" variability of the device's performance when used by practitioners of different expertise levels; and the availability of approved alternatives and their relative performance.
For diagnostic tests, the pivotal clinical study "is often a diagnostic clinical performance study," and the guidance states that a pivotal diagnostic clinical performance study "must support the intended use of the diagnostic device."
In designing the diagnostic clinical performance study, a developer needs to evaluate the device in that context. Criteria to be considered include what the device measures; what it reports; the cell, tissue, organ, part, or system that is examined; the specimen source, type and matrix; and how the device is used.
Also, the device should be evaluated based on the conditions of its use; who is using the device; the target condition; and the target population.