Medical Device Market Overview
From glucose meters to artificial heart valves, the medical device industry produces a broad range of diagnostic and therapeutic devices for the treatment and prevention of numerous patient health conditions. The FDA uses a class system to rank individual devices as low, intermediate, or high risk — Class I, II, or III, respectively. Higher risk devices face a more stringent Premarket Approval (PMA) process, while other devices will be assigned to follow a process for Premarketing Notification (510(k)) or may be exempt. Additional regulatory paths include Investigational Device Exemption (IDE), Humanitarian Device Exemption (HDE), Postmarket Device Reporting, and Postmarket Surveillance (522PMS).
Medical Device Clinical Trials
Class III (high risk) and some Class II (intermediate risk) devices are required to conduct clinical trials. These Medical Device studies face unique challenges compared to their pharmaceutical counterparts:
- Inability to blind patient and/or practitioner
- “Learning curve” effect for practitioners using new devices
- Operator variability
- Device trial design and selection of endpoints
- Potential malfunctions of device mechanisms
Medical Device Adjudication with ACI Clinical
An Endpoint Adjudication Committee can help to address the challenges listed above by providing a source of independent expertise to review Medical Device study data in a consistent manner. Adjudication of events of interest can support overall study integrity and ensure reliable, consistent definitions are provided to regulators and the scientific community.
ACI Clinical’s president chaired a March 2016 Thinktank Meeting on “The Role of Endpoint Adjudication in Medical Device Clinical Trials”, hosted by the Cardiac Safety Research Consortium (CSRC) and MDEpiNet with a great deal of FDA participants. At the event, it was recommended that the majority of medical device studies be adjudicated. A publication summarizing the recommendations and rationale is anticipated to be released in American Heart Journal in 2017.
ACI Clinical’s Device Adjudication Model
ACI recognizes there are many nuances in medical device adjudication compared to clinical drug trials. In general, device studies are often smaller, shorter and less expensive than clinical trials. ACI has therefore built a device adjudication model that is faster and cheaper than the traditional drug adjudication models. In addition, ACI works collaboratively with sponsors at the project start to understand their true objectives, whether it may be to gain regulatory approval, to gain reimbursement, or simply to promote awareness and recognition through publications, etc. ACI uses this information to develop and implement a cost certain, standardized adjudication process to effectively deliver what is needed for the sponsor.
Contact us today to learn more about Device Adjudication.
FDA Medical Device Regulations home page:
FDA Guidance Documents for Medical Device Trials: