Abbreviated IDE (Non-Significant Risk-NSR)
While there is no formal submission to the Food and Drug Administration (FDA) for a study evaluating the safety and/or effectiveness of an NSR device, per the FDA regulations at 21 CFR 812.2, compliance with a subset of the full device requirements is required. This is known as an Abbreviated IDE. These regulations outline the responsibilities for both the Sponsor and the Investigator. In addition, the regulations at 21 CFR 820 outline the requirements for compliance in manufacturing medical devices.
Here we offer a few simple educational materials and tools to assist University of Pittsburgh faculty working on NSR studies with complying with the abbreviated IDE regulations, as well as the design control regulations. The role of the faculty member in the study informs on which education and tools to access.
IMPORTANT NOTE: It is possible to be in one, two, or all three of the roles. In which case, refer to the links in all sections.
This is the person who initiated the study (i.e., is responsible for overall study preparation, planning and control). This may be an external organization (e.g., company manufacturing the device) or the individual Investigator. Since there is no submission to the FDA for an Abbreviated IDE, it is important to establish in writing who is the Sponsor before the study begins, so that there is a clear understanding of who is responsible for complying with the Sponsor requirements. In many cases, an Investigator would like to evaluate a device that is manufactured by a commercial entity.
- Evaluating safety or effectiveness of an FDA cleared (for marketing in the US) device for an off label use – evaluating the home use of a hemodynamic monitoring system rather than in the clinical setting.
- Evaluating a device meeting the FDA’s definition of a medical device in the study for safety or effectiveness – a recreational mobile app used as medical device, Apple Watch pulse oximetry feature, or a light box used to treat depression.
The individual who actually conducts a clinical investigation, i.e., under whose immediate direction the medical device is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.
The medical device is manufactured in a University or UPMC laboratory and will be evaluated for safety or effectiveness in the study.
The FDA Design Controls regulations (21 CFR 820.30) apply to all Class II and III medical devices. Design Controls also apply to the following Class I medical devices:
- Devices automated with computer software – includes mobile medical apps and artificial intelligence algorithms
- Catheter, Tracheobronchial Suction (Section 868.6810 of the CFR)
- Glove, Surgeon's (Section 878.4460 of the CFR)
- Restraint, Protective (Section 880.6760 of the CFR)
- System, Applicator, Radionuclide, Manual (Section 892.5650 of the CFR)
- Source, Radionuclide Teletherapy (Section 892.5740 of the CFR)
University-based device manufacturers should establish and maintain processes and procedures to control the design of the device so as to ensure that specified design requirements are met:
- Document all processes and related procedures
- Review/approve procedures
- Implement and adhere to defined procedures
- Review procedures periodically for current applicability
- Update procedures and review/approve revised procedures as warranted
Make your best effort to comply with requirements for Design Control – any level of compliance is better than no compliance!