This is very refreshing to see that the FDA is encourgaging manufacturers to design new imaging devices with protocols and instructions for pediatric patients. This is a start to make vendors, radiologists and radiographers aware of the importance of radiation protection. I understand it is the educational institutions that train radiographers are responsible to teach the proper use of radiation, but I strongly believe its the responsibility of the radiographer to perform safe radiation practices. As a registered radiographer who has taught students radiation protection and the biological effects of radiation, I welcome this notice. I found that theory and safe radiation practice are enforced as a student, but not strictly followed as a radiographer. I have a concern about the wording because to encourage means it is suggested and not required. I would like to see stronger language to make this a requirement with some type of repercussion. Thank you for allowing me to comment on this proposal.
Sandra Franklin - Comment
This is comment on Notice
Draft Guidance for Industry and Food and Drug Administration Staff; Availability: Pediatric Information for X-Ray Imaging Device Premarket Notifications
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