federal_register: 2017-25632
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2017-25632 | Pediatric Information for X-Ray Imaging Device Premarket Notifications; Guidance for Industry and Food and Drug Administration Staff; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled "Pediatric Information for X-ray Imaging Device Premarket Notifications." This guidance document outlines FDA's current thinking on information that should be provided in premarket notification submissions for x-ray imaging devices that are indicated for pediatric populations or general use x-ray imaging devices for which considerable pediatric application is anticipated. FDA intends for this guidance to minimize uncertainty during the premarket review process of premarket notification submissions for x- ray imaging devices for pediatric use to encourage the inclusion of pediatric indications for use for x-ray imaging device premarket notification submissions and to provide recommendations on information to support such indications. Both new devices and modifications of existing x-ray imaging devices that require submission of a new premarket notification are included within the scope of this guidance document, regardless of whether the device is a complete x-ray imaging system, a component part of an x-ray imaging device, or an accessory (e.g., detectors and software). | 2017-11-28 | 2017 | 11 | https://www.federalregister.gov/documents/2017/11/28/2017-25632/pediatric-information-for-x-ray-imaging-device-premarket-notifications-guidance-for-industry-and | https://www.govinfo.gov/content/pkg/FR-2017-11-28/pdf/2017-25632.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled "Pediatric Information for X-ray Imaging Device Premarket Notifications." This guidance document outlines FDA's current thinking on information... |