{"database": "openregs", "table": "federal_register", "rows": [["2012-11260", "Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-Ray Imaging Device Premarket Notifications; Availability", "Notice", "The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled \"Pediatric Information for X-ray Imaging Device Premarket Notifications.\" This draft guidance document outlines FDA's current thinking on information that should be provided in premarket notifications for x-ray imaging devices with indications for use 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. This draft guidance applies only to complete x-ray imaging devices that could be used on pediatric patients. This draft guidance is not final nor is it in effect at this time.", "2012-05-10", 2012, 5, "https://www.federalregister.gov/documents/2012/05/10/2012-11260/draft-guidance-for-industry-and-food-and-drug-administration-staff-pediatric-information-for-x-ray", "https://www.govinfo.gov/content/pkg/FR-2012-05-10/pdf/2012-11260.pdf", "Health and Human Services Department; Food and Drug Administration", "221,199", "The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled \"Pediatric Information for X-ray Imaging Device Premarket Notifications.\" This draft guidance document outlines FDA's current thinking on information...", null]], "columns": ["document_number", "title", "type", "abstract", "publication_date",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": ["2012-11260"], "units": {}, "query_ms": 0.7194241043180227, "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"}