News
- U of MN PDIC becomes part of FDA-funded Pediatric Consortium
- U of M researches work on heart valve for kids
- University of Minnesota volunteer group looks to kick-start development of medical devices for kids
- Minneapolis med-tech conference explores next big thing
Resources
Non PDIC Funding Opportunities and other Support
- NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs
- FDA Pediatric Consortia Program
Regulatory
FDA Medical Device Regulation guidance
CDRH Guidance Documents Related to Pediatric and Rare Disease Issues
- Providing Information about Pediatric Uses of Medical Devices (Pediatric Tracking, May 2014)
- Draft Guidance: Expedited Access for Premarket Approval of Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions (April 2014)
- Draft Guidance: Balancing Premarket and Post-market Data Collection for Devices Subject to Premarket Approval (April 2014)
- Premarket Assessment of Pediatric Medical Devices (March 2014)
- Draft Guidance for HDE Holders, IRBs, Clinical Investigators, and FDA Staff - Humanitarian Device Exemption (HDE) Regulation (March 2014)
- Draft Guidance: Reporting of Computational Modeling Studies in Medical Device Submissions (January 2014)
- Custom Device Exemption (January 2014)
- Design Considerations for Pivotal Clinical Investigations for Medical Devices (November 2013)
- Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications (March 2012)
- Mobile Medical Applications (Draft, July 2011)
- Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (February 2010)
- FDA Decisions for Investigational Device Exemption Clinical Investigations (August 2014)
- Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies (October 2013)
- Design Considerations for Pivotal Clinical Investigations for Medical Devices (November 2013)
- Draft Guidance: Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States (April 2015)
Intellectual Property