For privately sponsored studies that are conducted pursuant to a private sponsor’s protocol (industry sponsor), the sponsor of the study is required to pay for the reasonable cost of treating injuries or complications directly resulting from participation in the study, including injuries or complications resulting from the study material or research procedures performed pursuant to the study protocol, to the extent that injuries/complications were not a result of negligence, willful misconduct or failure to reasonably act on the part of the study personnel.
The Office for Research Protections Quality Assurance Program is available to assist with IND preparation, submission, and maintenance. Contact them at orp-qm@psu.edu.
For guidance and templates for your IND application, see the Quality Assurance Program’s resources.
Sponsor-Investigator responsibilities under an IND or IDE are covered in 21 CFR 312 (for drugs) and 21 CFR 812 (for devices).
For more information on Humanitarian Use Devices, see the information provided by the College of Medicine.
Premarket approval (PMA) (21 CFR 814.39) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Due to the level of risk associated with Class III devices, FDA requires sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s).
For more information on Emergency Use of Unapproved Device, Compassionate Use, and Treatment Use, please see the information provided by the College of Medicine.
Some studies may be exempt from the IDE regulations. The exemption criteria is explained in 21 CFR 812.2(c), and briefly summarized here:
Studies of non-significant risk devices are subject to abbreviated IDE requirements. An IDE submission to the FDA is not required under the abbreviated requirements, but the requirements for labeling, IRB approval, informed consent, monitoring, records, reports and promotional practices contained in FDA regulations still apply (21 CFR 812.2(b)).
Requirements under abbreviated IDE: