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.
Medical Device Approval Process
Device manufacturers are required to register annually with The U.S. Food and Drug Administration (FDA) and to list the devices they produce. The devices themselves are subject to regulatory reviews which assess device safety and efficacy.
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), Post market Device Reporting, and Post market Surveillance (522PMS).
Medical Device Clinical Trials
All 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
An Endpoint Adjudication Committee can help to address these challenges by providing a source of independent expertise to review Medical Device study data. Adjudication of clinical safety and efficacy events of interest can support overall trial integrity and ensure reliable, consistent definitions are provided to regulators and the scientific community.
Endpoint Adjudication is thought to be helpful in studies with the following characteristics:
- Complex and/or subjective endpoints
- Study cannot be blinded
- Global or cultural differences across sites
- Endpoint of interest differs from the investigator’s therapeutic specialty
As an industry-leading provider of clinical trial expert committees and clinical safety and consulting services, ACI Clinical is available to support and assist you with any Medical Device trial Endpoint Adjudication or clinical consulting needs. ACI brings clients the largest dedicated committee staff in the industry, a global network of qualified medical experts that can serve as members, and a proprietary technology designed for adjudication workflows.
FDA Medical Device Regulations home page:
FDA Guidance Documents for Medical Device Trials:
ACI Clinical will participate in an expert think tank exploring The Role of Adjudication in Medical Device Clinical Trials in Washington, DC, on March 11, 2016.