Links

Provides an overview of the FDA's PDC program, of which we are part

 

Provides guidance regarding device classification, basic regulatory requirements for approval, Quality System regulation, labeling requirements, and medical device reporting

 

  • 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Draft Guidance: Expedited Access for Premarket Approval of Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or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Draft Guidance: Balancing Premarket and Post-market Data Collection for Devices Subject to Premarket Approval (April 2014)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Draft Guidance for HDE Holders, IRBs, Clinical Investigators, and FDA Staff - Humanitarian Device Exemption (HDE) Regulation (March 2014)

Draft Guidance: Reporting of Computational Modeling Studies in Medical Device Submissions (January 2014)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Draft Guidance: Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States (April 2015)

Click here to search for other guidance documents 

 

Allows you to search the database of issued U.S. patents

 

A partner organization of the PPDC. NAMSA is a medical research organization providing expert regulatory, laboratory, clinical, and compliance services to medical device and healthcare product manufacturers. 

 

Provides information about the NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, including opportunities to apply for federal funding to support small companies in research and development that has a strong potential for commercialization

 

  • To access the other Pediatric Device Consortia:

University of Michigan Pediatric Device Consortium

Atlantic Pediatric Device Consortium

National Capital Consortium for Pediatric Device Innovation

New England Pediatric Device Consortium

Center for Technology and Innovation in Pediatrics

Pediatric Device Consortium