Providing Information About Pediatric Uses Of Medical Devices

Providing Information about Pediatric Uses of Medical …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-information-about-pediatric-uses-medical-devices

Providing Information about Pediatric Uses of Medical Devices Guidance for Industry and FDA Staff May 2014. Providing Information about Pediatric Uses of Medical Devices. Section 302 of Title III ...

Pediatric Medical Devices | FDA

https://www.fda.gov/medical-devices/products-and-medical-procedures/pediatric-medical-devices

Pediatric medical devices treat or diagnose diseases and conditions from birth through age 21. The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines pediatric …

Draft Guidance for Industry and FDA Staff

https://www.fda.gov/media/85233/download

Providing Information about Pediatric Uses of Medical Devices . Guidance for Industry and Food and Drug Administration Staff . Document issued on: May 1, 2014

Providing Information About Pediatric Uses of Medical …

https://www.federalregister.gov/documents/2014/05/01/2014-09897/providing-information-about-pediatric-uses-of-medical-devices-guidance-for-industry-and-food-and

Providing Information about Pediatric Uses of Medical …

https://www.hhs.gov/guidance/document/providing-information-about-pediatric-uses-medical-devices-guidance-industry-and-fda-staff

Final. Issued by: Food and Drug Administration (FDA) Issue Date: May 01, 2014 DISCLAIMER: The contents of this database lack the force and effect of law, except …

Federal Register :: Medical Devices; Pediatric Uses of …

https://www.federalregister.gov/documents/2014/01/10/2014-00267/medical-devices-pediatric-uses-of-devices-requirement-for-submission-of-information-on-pediatric

FDA is codifying a definition of “readily available” and Start Printed Page 1737 will be issuing a guidance document entitled “Guidance for Industry and Food and Drug …

Leveraging Existing Clinical Data for Extrapolation to …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/leveraging-existing-clinical-data-extrapolation-pediatric-uses-medical-devices

The objectives of this guidance are: (1) to increase the availability of safe and effective pediatric devices by providing a roadmap for leveraging relevant existing clinical data …

Federal Register :: Medical Devices; Pediatric Uses of …

https://www.federalregister.gov/documents/2010/04/01/2010-7192/medical-devices-pediatric-uses-of-devices-requirement-for-submission-of-information-on-pediatric

The information submitted will allow FDA to track the number of approved devices for which there is a pediatric subpopulation that suffers from the disease or …

Off-Label Use of Medical Devices in Children - Pediatrics

https://publications.aap.org/pediatrics/article/139/1/e20163439/52002/Off-Label-Use-of-Medical-Devices-in-Children

The off-label use of a medical or surgical device is analogous to the common off-label use of many medications in children. 6. For children, off-label and HDE …

Young Children’s Use of Smartphones and Tablets

https://publications.aap.org/pediatrics/article/146/1/e20193518/77025/Young-Children-s-Use-of-Smartphones-and-Tablets

Address correspondence to Jenny S. Radesky, MD, Department of Pediatrics, Medical School, University of Michigan, 300 N Ingalls St, Room 1107, Ann Arbor, MI …