{"database": "openregs", "table": "federal_register", "rows": [["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...", null]], "columns": ["document_number", "title", "type", "abstract", "publication_date", "pub_year", "pub_month", "html_url", "pdf_url", "agency_names", "agency_ids", "excerpts", "regulation_id_numbers"], "primary_keys": ["document_number"], "primary_key_values": ["2017-25632"], "units": {}, "query_ms": 0.41879015043377876, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}