FDA encourages researchers to contact the FDA early to discuss clinical study plans and get informal feedback that can improve their study designs and facilitate the review process.
In addition, researchers may find the following resources useful when planning studies and preparing documents for FDA review.
Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff - Guidance for Industry and Food and Drug Administration Staff(PDF - 297KB)
- Final Guidance for Industry and the Food and Drug Administration Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems (PDF - 847KB)
- Guidance Document on Investigation Device Exemption (IDE) Policies and Procedures
Infusion Pumps Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Device Advice: Comprehensive Regulatory Assistance
- The regulation which provides information about PMAs can be found in the Code of Federal Regulations, CFR 21 814
- Information regarding research and funding opportunities with the National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).