The U.S. Food and Drug Administration (FDA) is asking for comment on a new guidance designed to streamline and otherwise accelerate the approval process for certain medical devices.
The Breakthrough Devices Program (BDP) is a voluntary program for some medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
While the guidance is wide in scope, portions of it address the important role of clinical trials in the process.
FDA says it intends to “take steps to ensure that the design of clinical trials is as efficient and flexible as practicable, when scientifically appropriate.” This may include, for example, consideration of the following:
- prespecified endpoints regarding the minimum clinically meaningful effect;
- intermediate and surrogate endpoints where evidence is provided to support the endpoint as reasonably likely to predict the clinical benefit of a device;
- composite endpoints with an explicit rationale for the meaningful effect size; and
- phased study design.
The BDP also offers a mechanism for obtaining agreement in writing for clinical protocols, which will be considered binding on both FDA and the sponsor, subject to the following:
- Any changes to the previously agreed-upon protocol are agreed upon in writing by both FDA and the sponsor; or
- The director of the Office responsible for reviewing the device submission determines that a substantial scientific issue essential to determining the safety or effectiveness of the device exists. In this case, the director’s decision must be provided in writing and can be made only after FDA has provided an opportunity to the sponsor to meet and discuss the substantial scientific issue(s). Such a meeting would need to include the Office director and clearly document the substantial scientific issue(s) discussed.
In the guidance, FDA says it will work interactively with sponsors who choose to pursue a clinical protocol agreement. Upon reaching agreement, FDA will issue a letter documenting that agreement.
FDA seeks comments within 60 days of the guidance’s October 25, 2017 publication date. Identify all comments with the docket number listed in the notice of availability published in the Federal Register.
Submit comments via the regulations.gov website.
Author: Michael Causey