MPSS Presentations
Investigator Initiated Device Research
- Investigator Initiated Device Research Handbook (Secure Login Required)
- Human Research Protection Program
- Vanderbilt Institute for Clinical and Translational Research (VICTR)
FDA Links and resources
- FDA Medical Device Home Page
- FDA Device Advice: Comprehensive Regulatory Assistance
- CDRH Learn based series of teaching modules, seminars, and recorded webinars that cover a variety of policy and guidance efforts
- How to Study and Market Your Device, Device classification
- Early Feasibility Study Guidance
- CDRH Pre-submission Program- -prospective applicants of future premarket submissions may request feedback from the FDA through this program. Information about this resource maybe found in the FDA guidance Request for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff.
- FDA Recognized Consensus Standards – use for guidance for pre-clinical testing requirements for various devices
- 510(k) Overview
- 510(k) Searchable Database
- 510(k) guidance
- De Novo guidance -- The de novo process provides a pathway
- Risk assessment for medical devices – use the international standard ISO 14971
- Benefit – Risk Assessment Guidance
- Software validation guidance
- Mobile Medical Apps guidance
- Clinical Decision Support Software