CDRH will identify public health challenges and opportunities and collaborate with our partners in federal government and external constituencies to foster innovative solutions.
Strategy 4.1. Foster the Development of Innovative Medical Devices
CDRH will work with our federal government partners and external constituencies to facilitate the development of innovative medical technologies and devices.
Goal 4.1.1. By September 30, 2011, CDRH will take additional steps to facilitate the development of innovative medical devices and medical devices to address unmet public health needs.
- By June 30, 2011, provide a progress report on at least 2 pilot programs developed to address unmet public health needs identified by the Council on Medical Device Innovation and provide an updated list of the top 5 unmet public health needs that could be cured, significantly improved, or prevented by the development or redesign of a medical device.
- By September 30, 2011, identify the barriers to utilization and optimal performance of CDRH's expedited review process and propose solutions.
- By September 30, 2011, identify external partners and hold a public workshop to promote advances in medical device computational modeling and simulation.
- By September 30, 2011, identify the initial steps necessary to establish at least one medical device regulatory science public-private partnership.
Goal 4.1.2. By December 31, 2011, CDRH will establish a framework for the use of published literature as sufficient evidence to support pediatric device claims.
- By June 30, 2011, hold a public workshop to solicit input from constituencies on the use of published literature and registries as sufficient evidence to support pediatric device claims.
- By December 31, 2011, clear within CDRH a white paper on the use of published literature and registries as sufficient evidence to support pediatric device claims.
Goal 4.1.3. By July 31, 2011, CDRH will develop and implement a Medical Device Innovation Initiative to facilitate the development and regulatory evaluation of innovative medical products.
- By February 28, 2011, develop an Innovation Initiative white paper outlining additional steps CDRH can take to facilitate innovative product development such as expediting first-in-human trials and streamlining CDRH's review of innovative products.
- By May 31, 2011, solicit feedback from constituencies on the proposed steps outlined in the Innovation Initiative.
- By July 31, 2011, begin implementation of identified steps.
CDRH will work collaboratively with other FDA Centers to assure the appropriate regulatory oversight of therapeutics and diagnostics when their safety and efficacy are intimately tied to one another.
Goal 4.2.1. By March 31, 2011, CDRH will establish a framework for the review of submissions addressing genomic tests.
- By January 31, 2011, finalize a framework for validation and review of array CGH applications.
- By March 31, 2011, hold a public meeting to provide advice and recommendations to the Agency on scientific, clinical practices, and other issues that will inform FDA’s regulatory actions on Direct to Consumer (DTC) genetic testing indications.