Submit a Project
MDIC projects are conducted in the precompetitive space and support these objectives:
- Advance the field of medical device regulatory science and its acceptance and use by the device industry.
- Promote collaboration and innovation among the Medical Device Stakeholders.
- Create scientific tools that will assist Medical Device Stakeholders in developing new medical device products and in assessing the safety and effectiveness, quality, and performance of these products.
- Provide education about the medical device regulatory process.
- Provide education about the needs of the medical device community that will increase the throughput of innovation.
- Make the medical device regulatory process more expeditious, transparent, and effective.
- Work to make state-of-the-art health care technology available to those who need it with a goal of making U.S. patients “first in the world” with access.
- Validate and qualify new methods, tools, approaches, and standards so that CDRH will adopt them as part of the regulatory process.
Project concept submission process:
Submissions are reviewed on a rolling basis and final project approval is made by the MDIC Board of Directors.
Approval of a project concept is based:
- Clarity of the objective.
- Alignment with MDIC objectives.
- Broad member organization support.
- Feasiblity and potential to generate multi-stakeholder funding.
- Resource availability to support the project.