Most PMAs and a small percentage of 510(k)s require clinical data to support the application. Good Clinical Practice (GCP) regulations apply to any clinical study of a device, whether that devices poses a significant risk (SR) or not (NSR) (see this guidance on the definitions of SR and NSR). In order to collect safety and effectiveness data on a SR device, the sponsor must obtain Investigational Device Exemption (IDE) approval from the FDA. All devices undergoing clinical evaluation require:

• an investigational plan approved by an institutional review board (IRB;
• informed consent from all patients;
• labeling stating that the device is for investigational use only;
• monitoring of the study and;
• the records and reports required by the GCP regulations.

The IDE application process is detailed; however, the FDA updated the program in 2013 to improve patient access to new medical devices under the MDUFA III commitments. The new IDE submission structure is similar to the PMA submission structure. After submission of an original IDE, the FDA tracks subsequent submissions to the IDE as Supplements, Reports, or Amendments. Supplements cover changes to the device, Reports detail the progress of clinical trials, and Amendments are submissions sent to correct deficiencies in the application. The changes also implement separate tracking of Emergency Use Authorizations (EUA) and Pre-Emergency Use Authorizations (PEUA) from IDEs. EUA and PEUA support emergency preparedness by allowing use of medical devices as emergency countermeasures to diagnose, treat or prevent serious or life-threatening diseases or conditions caused by chemicals agents, when there are no adequate, approved, and available alternatives.

If you are planning for clinical trials with your device, the IDE web page covers the IDE application process and requirements in detail. See my next post on the guidance for SR and NSR devices, too.

Text Copyright © 2019 Katrina Rogers