• Decrease
  • Normal
  • Increase
U.S. Department of Health and Human Services

About FDA

Foster the Development of Medical Devices to Respond to Unmet Public Health Needs

Description: Identify important unmet public health needs and work with our federal government partners and external constituencies to take steps to reduce these barriers. Unmet public health needs are defined as illnesses and injuries that: (i) are serious or have a moderate adverse impact on health but affect many individuals; (ii) could be cured, significantly improved, or prevented by the development or redesign of a device; and (iii) the device(s) is not being developed or redesigned due to barriers that the federal government can directly or indirectly remove or minimize.

Accomplishment: The Council on Medical Device Innovation, comprised of eight federal government partners, convened a public workshop in June 2010 to identify areas of unmet public health need that could be addressed through medical device and/or radiation emitting products. The five areas identified in 2010 included two settings, wireless health care and home use of devices, and three medical targets, diabetes, spinal cord injury, and cancer. To solicit innovative solutions to one of the identified unmet public health needs, diabetes, CDRH and the Defense Advanced Research Projects Agency (DARPA) are holding a workshop on February 9, 2011 (see FR notice). The workshop will focus on the technical challenges for developing implanted or continuously applied devices capable of measuring and monitoring clinically relevant molecular biomarkers (small molecules, proteins, peptides, and nucleic acids) to alert the user of the need for clinical attention and/or to inform the clinician with regard to appropriate action.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Establish a Council on Unmet Public Health Needs (Council) composed of participants from federal agencies

3/31/2010

Completed 3/31/2010

B. Hold one or more public workshops to identify the most important unmet public health needs and the barriers to the development of medical devices that can cure, significantly improve, or prevent these illnesses or injuries

6/30/2010

Completed 6/24/2010

C. Hire a medical device innovation coordinator

7/31/2010

Completed 11/30/2010

D. Identify feasible, high return-on-investment options to solicit innovative solutions to unmet public health needs from external constituencies

9/30/2010

Completed 9/30/2010

E. Identify key agency staff who will devote at least part of their time to medical device innovation and establish roles and responsibilities

9/30/2010

Completed 9/30/2010

F. Identify the steps the federal government can realistically take to remove or minimize barriers to the development of devices that respond to two or more of the top five most important unmet public health needs.

9/30/2010

Completed 9/30/2010

G. Implement one to two of the identified high return-on-investment options to solicit innovative solutions to unmet public health needs from external constituencies across all devices or for specific types of devices.

9/30/2010

Completed 10/31/2010

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.