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FDA RELEASES SUMMARY FROM PEDIATRIC DEVICES WORKSHOP

February 23, 2006

The FDA recently released a summary from an agency workshop on the regulatory process for pediatric mechanical circulatory support devices or ventricular assist devices described the regulatory process for pediatric ventricular assist device approval.

Joanne Less, associate director of clinical research and government affairs at the FDA's Center for Devices and Radiological Health, discussed new pediatric provisions, such as the guidance on data necessary to support device approval and on the protection measures for pediatrics in clinical trials.

Some of the proposed solutions to unmet pediatric needs included enhancing information exchange between FDA and the clinical community, encouraging pediatric discussion at Pre-IDE meetings and clarifying the marketing requirements for pediatric devices. The challenge, said Less, will be to encourage the development of pediatric devices without increasing the risk to pediatric patients, increasing burden on industry or the FDA, or delaying device approval for adults.

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