# Device Frequently Asked Questions

### 1. What sorts of activities are out of scope for this NOFO?

For the purposes of this program announcement technologies for augmentation of healthy individuals, rehabilitation strategies, imaging technologies, diagnostics and diagnostic devices are not considered therapeutic devices and should not be submitted. In addition, the following activities are also not within scope:
              - Basic research and studies of disease mechanisms
              - Animal model development: All in vivo models must have been established and characterized in the applicants or collaborators laboratory.
              - Definitive clinical trials, such as a full Feasibility study and/or Pivotal Trial
              - Applications without pre-clinical testing or activities
              - Applicants proposing clinical trials or biomarker studies that fall outside of the scope of this NOFO may wish to consider applying to the NINDS NeuroNEXT clinical trials program, the NINDS Exploratory Clinical Trials program (PAR-17-122), or to the NIH StrokeNet program (link is external) for stroke indications
              - Efforts to develop neurotechnology for fundamental study of the nervous system
              - Fundamental basic/applied research projects that employ existing market approved devices for their labeled uses are outside the scope of the present NOFO but may be within scope of the Bioengineering Research Grants and Partnerships program announcements.

### 2. Do I have to contact FDA or have a pre-submission meeting prior applying?

Contacting the FDA and/or having a pre-submission meeting is not required to apply, but is encouraged. Pre-submissions can provide extensive, useful feedback that may improve an application. Further, though time intensive, pre-submission meetings are *free*.

### 3. What is a Study Monitoring Committee (SMC) and who should be on it?

              - An SMC is a group of people (generally physicians and a statistician), appointed by the principle investigator(s) in consultation with NIH program staff, who oversee the data and safety monitoring for a study not monitored by a Data and Safety Monitoring Board (DSMB). Members of an SMC must be independent from the study, but may be from the same institute. NIH program staff must approve the SMC membership and the specific monitoring procedures, and may participate in SMC meetings.
              - PIs are encouraged to include at least one SMC member from outside the study institute.
              - PIs are encouraged to appoint an odd number of SMC members (typically 3 or 5) to guard against disagreements.
              - For additional information and to help determine the level of monitoring necessary for your study, see NINDS Guidelines for Monitoring in Clinical Trials.

### 4. What is a Scientific Steering Group (SSG) and who should be on it?

Scientific Steering Group that consists of representatives from each of the partnering organizations and meets regularly to discuss project status, problems, and directions. Those individuals identified in the team management plan, who together would have the intellectual and leadership responsibilities, would likely be members of the Scientific Steering Group. Technology transfer officials from the participating organizations are also encouraged to be members of the Scientific Steering Group. Plans for enhancing the abilities and opportunities for investigators to work across disciplinary boundaries should also be included.

### 5. What is a cooperative agreement?

As cooperative agreement is a support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. Applicants are strongly encouraged to consult with NIH Scientific/Research staff when planning a cooperative agreement application. Early contact provides an opportunity for Scientific/Research staff to provide further guidance on program scope, goals, and developing appropriate milestones. Applicants should contact Scientific/Research staff at least 12 weeks before a receipt date. 

Cooperative agreements are milestone-driven and involve significant input from NIH program staff regarding project and milestone planning, monitoring of research progress, and go/no-go decision-making. The expectations of the program are in line with those of industry in regards to advancing devices through the developmental pipeline. As such, an inherent risk of attrition is possible within this program.

### 6. What are milestones?

Milestones are clear go/no-go decision points based on quantified metrics used to measure project progress and efficacy. Milestones are used to determine:
              - What should be included
              - How many

### 7. What is SBIR eligibility criteria?

See the SBIR website to address the answer to this question

### 8. How do I address Rigor?

NIH encourages increasing the rigor and reproducibility of observed results. In some cases, conducting additional critical experiments will be important for NIH to have confidence in making a funding decision. Therefore, program staff may add experiments that need to be conducted prior to or during the award as an additional milestone(s). In most cases, these studies will be supported by additional funds.

### 9. Are re-submissions allowed? (from CREATE devices)

Yes, but only 1 resubmission is allowed. However, substantially equivalent new submissions are always allowed. Please note, resubmissions must follow the NIH Policy for resubmitting applications.