The FDA will hold a public meeting next month on the regulation and approval of circulatory support devices used for temporary support in pediatric patients.
The meeting, titled 'Regulatory Process for Pediatric Mechanical Circulatory Support Devices (Ventricular Assist Devices)," will aim to provide the medical device community with guidance on the approval process for ventricular assist devices used in pediatric patients in need of temporary support, including the left side, right side or both sides.
The FDA will address applications for premarket approval, humanitarian use designations, humanitarian device exemptions, and investigational device exemptions. The FDA also will present information on preclinical engineering qualification of pediatric mechanical circulatory support devices. Invited experts will discuss medical and surgical topics related to the devices.
For more information, access http://www.fda.gov/OHRMS/DOCKETS/98fr/05-0485-nm00001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/05-0485-nm00001.pdf).