The US Food and Drug Administration (FDA) announced it is releasing new draft guidance for industry on what information needs to be contained with a company's premarket notification for any x-ray device intended to be used in pediatric populations.
"FDA intends for this guidance to minimize uncertainty during the premarket review process of 510(k)s for x-ray imaging devices for pediatric use, to encourage the inclusion of pediatric indications for use for x-ray imaging device premarket notifications, and to provide recommendations on information to support such indications," said FDA in a statement released in the Federal Register on 9 May.
FDA noted most x-ray devices coming to market right now are marketed using general indications for use (IFU) while neglecting the "unique issues associated with pediatric use," including pediatric patients' specific needs.
These needs include the radiosensitivity of children, the long-term exposure risks for children exposed to radiation and the possibility of children receiving an adult-sized dose of radiation if screened in a device designed for use in adult populations.
The latter point "is of special concern because many pediatric imaging exams are performed in facilities lacking specialized expertise in pediatric imaging," explains FDA.
"FDA believes the new x-ray imaging devices should be demonstrated to be appropriate for pediatric use or use in pediatric populations should be cautioned against," notes FDA. "The end user can then make more informed decisions about use of the device on pediatric patients."
Manufacturers looking to market their products to populations that include children must "provide data supporting the safety and effectiveness of the device in pediatric populations," writes FDA.
Those manufacturers intending only to market their devices to adult populations must provide a prominent disclaimer on their x-ray device saying it is not intended for use in pediatric populations.
FDA also said it will conduct a public meeting to discuss the draft guidance on 16 July 2012 at its White Oak campus in Silver Spring, MD.
FDA - Draft Guidance for Industry and Food and Drug Administration Staff; Availability: Pediatric Information for X-Ray Imaging Device Premarket Notifications
FDA - Draft Guidance for Industry and Food and Drug Administration Staff - Pediatric Information for X-ray Imaging Device Premarket Notifications
FDA - Meetings: Device Improvements for Pediatric X-Ray ImagingAssociated Press - FDA: Kids' medical tests need child-size radiation