federal_register: 2012-11260
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2012-11260 | Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-Ray Imaging Device Premarket Notifications; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Pediatric Information for X-ray Imaging Device Premarket Notifications." This draft guidance document outlines FDA's current thinking on information that should be provided in premarket notifications for x-ray imaging devices with indications for use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 This draft guidance applies only to complete x-ray imaging devices that could be used on pediatric patients. This draft guidance is not final nor is it in effect at this time.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Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Pediatric Information for X-ray Imaging Device Premarket Notifications." This draft guidance document outlines FDA's current thinking on information... |