Devices which are more mature in their development are candidates for device testing within the Centers reserach labs or clinics. Enabling technologies which do not include a detection device are also candidates, however, organizations must identify the detection technology or platform to be paired with their technology.
Details and Requirements:
- An NDA and IRB-approved protocol(s) will be required.
- Minimally, the Center IRB must approve the study, though organizations may have requirements for their own approvals.
- Organizations are encouraged to provide the reagents and devices to the Center for evaluation in the research laboratory or clinical settings.
- Additional financial support in the form of patient incentive/sample collection reimbursements, devices, and training may be required depending on the level of effort requested from the Center.
- Companies qualifying for this support should have a similar device which is 510K approved, FDA approved or in the path for FDA approval, and/or European Community, also known as European Compliance (CE), marking.
- Publications from these studies will be encouraged.
- Data generated from these studies will be the property of the participating organization, however, the Center will be included in any open source publications of these data.
- Data generated is required to be included in any limited distribution formal government documents as required by Federal Acquisition Regulation standards. These will include but are not limited to final reports required at the conclusion of IRB approved studies and annual or final FOUO reports to government sponsors.