Request For Information: Needs for and Impediments to the Development of Pediatric Medical Devices

The purpose of this Web site is to collect responses to the "Request For Information: Needs for and Impediments to the Development of Pediatric Medical Devices" as described in the NIH Notice HL-08-121 (see http://grants.nih.gov/grants/guide/notice-files/NOT-HL-08-121.html). The RFI invites the scientific community, health professionals, patient advocates, and the general public to provide comments and suggestions on the issues below. Please provide your responses by July 3, 2008. When providing responses, please avoid including any personally identifiable or other sensitive information.

1. Identify unmet medical needs for pediatric populations that could be addressed by medical devices for diagnosing, treating or curing pediatric diseases or conditions. Comments should include a statement whether a new device may be required or if existing medical devices could be adapted for the intended use in the relevant pediatric population. If possible, include information on the disease or condition such as the number of patients who could benefit, age ranges of those patients, natural history, current diagnostic and treatment options, and current health outcomes. In addition, please provide anticipated pediatric health outcomes and, if feasible, potential economic impacts that could result if the new or applicable device were to become available.

Identify unmet medical needs for pediatric populations that could be addressed by medical devices for diagnosing, treating or curing pediatric diseases or conditions. Comments should include a statement whether a new device may be required or if existing medical devices could be adapted for the intended use in the relevant pediatric population. If possible, include information on the disease or condition such as the number of patients who could benefit, age ranges of those patients, natural history, current diagnostic and treatment options, and current health outcomes. In addition, please provide anticipated pediatric health outcomes and, if feasible, potential economic impacts that could result if the new or applicable device were to become available.

2. Identify obstacles to developing pediatric devices and provide recommendations for overcoming them. Recommendations may include specific funding mechanisms or programs that would enhance pediatric device development (e.g. public-private partnerships) or the application of scientific resources (e.g. the use of biomarkers, extrapolation of data from adult use, and standardized outcome measures).

Identify obstacles to developing pediatric devices and provide recommendations for overcoming them. Recommendations may include specific funding mechanisms or programs that would enhance pediatric device development (e.g. public-private partnerships) or the application of scientific resources (e.g. the use of biomarkers, extrapolation of data from adult use, and standardized outcome measures).

3. Identify any ethical issues related to device development in children, particularly in non-emergency settings, that should be addressed when planning a device development program.

Identify any ethical issues related to device development in children, particularly in non-emergency settings, that should be addressed when planning a device development program.

4. Identify essential criteria to assess the overall public health need, priority, and commercial potential of pediatric medical devices. If possible, provide specific details on the types of desired clinical and non-clinical studies, the type and extent of data to be collected, health outcomes, projections for use, costs of scale up and manufacture, financial projections, etc. that would be relevant for a systematic evaluation to decide if a project should continue development and seek commercialization.

Identify essential criteria to assess the overall public health need, priority, and commercial potential of pediatric medical devices. If possible, provide specific details on the types of desired clinical and non-clinical studies, the type and extent of data to be collected, health outcomes, projections for use, costs of scale up and manufacture, financial projections, etc. that would be relevant for a systematic evaluation to decide if a project should continue development and seek commercialization.

5. Provide input on current pediatric device regulatory requirements.

Provide input on current pediatric device regulatory requirements.