A member of the NESTcc team will contact you within one week of submitting your request. If you would like to share additional information about your request, it can be sent to NESTcc@mdic.org.
If you have feedback on the form or process, please feel free to share that. We are interested in your feedback so that we can improve our processes.
NESTcc does not participate in discussions with the FDA regarding the suitability of any product-specific submissions from medical device companies. Medical device companies should continue to follow their established procedures and work directly with the FDA to discuss the acceptability of any proposed study in terms of study design, sample size, selection of outcomes. Medical device companies are also responsible for determining whether any regulatory requirements, such as compliance with the FDA’s Investigational Device Exemption (IDE) regulations, apply to the research in question and for complying with those requirements. If you have any questions, please contact the NESTcc.
NESTcc funds may be awarded under a federal grant and any sub-awards must follow the same rules. Network Collaborators that receive a federal sub-award from NESTcc will be responsible for following the appropriate federal guidelines. In addition, Network Collaborators, along with medical device companies, will be responsible for ensuring that any study meets all applicable regulatory requirements, including regulations associated with obtaining informed consent, providing for review by an Institutional Review Board and potentially compliance with the Investigational Device Exemption (IDE) regulations, among others. We encourage the Network Collaborators to engage with the industry partner to review these requirements.
The information submitted through this form will be reviewed by MDIC staff within the NESTcc. Submitted information will not be shared beyond MDIC staff without prior approval from the submitting organization.