New FDA Guidance on Paediatric Information for X-Ray Device Premarket Notifications

On May 10 2012, the FDA released new draft guidance on "Paediatric Information for X-ray Imaging Device Premarket Notifications". This new guidance provides health professionals with guidelines enabling them to use the imaging equipment already in use at their facilities safely on paediatric patients. This guidance applies only to complete x-ray imaging devices that could be used on paediatric patients.

 

FDA encourages manufacturers to consider the safety of children in the design of new X-ray imaging devices, so as to reduce unnecessary radiation exposure from medical imaging in paediatric populations as:

Currently, X-ray equipment is marketed for general use with labelling that does not address paediatric concerns; radiological devices are sold without appropriate design features that would help users optimize benefits in comparison to risk of exposure. New draft guidance outlines information that should be provided in premarket notifications / 510(k) submissions for x-ray imaging devices with indications for use so as to minimize uncertainty during the premarket review process.

 

The 510(k) submission should include:

FDA in collaboration with manufacturers and imaging experts aims to improve x-ray imaging devices by incorporating radiation protection principles into facility quality assurance, personnel credentialing and training requirements for improvements in device design and instructions for use.

 

 

 

 

Submitter of 510(K) application should provide a statement of the intended use and in case the imaging device has specific indications for use, a detailed explanation so as to prove that the differences do not affect the safety and effectiveness of the device should be provided. Any performance characteristics expected to change based on the size of the object being imaged should be tested in prior.

 

Contraindications, warnings, and precautions should clearly address the potential risks and their association with the age, size, and condition of the paediatric subject and alert the end-user to specific hazards associated with the use of the device in the target population.

 

Instructions for use should outline the technological features, proper configuration and how the device is to be used on patients and should address radiation dose reduction strategies for paediatric populations while considering the likely educational background of the end-user.

 

Quality control recommendations should include information about specific tests conducted at periodic intervals which ensure the efficiency of the device when used on paediatric populations and instructions or guidelines to the user on how to ensure its continued proper operation.

 

The imaging device description should describe specific features related to typical paediatric populations after consultation with professionals in the field in order to ensure the device is suitable for paediatric use.

 

Premarket notifications should include a rationale for the selected size/age subgroups for image quality or dose measurements that involve discrete measurements in phantoms and testing procedures. Any device features that are expected to vary depending on patient size should be evaluated for acceptable outcomes.

 

Clinical images should be accompanied with corresponding information when there is insufficient evidence to demonstrate substantial equivalence.

 

Training program materials, user manuals should be provided to the end user and the 510(k) submission should include a description of the training materials for the device.