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Pediatric Medical Devices | FDA
- https://www.fda.gov/medical-devices/products-and-medical-procedures/pediatric-medical-devices
- 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...
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 DOCUMENT Providing Information about Pediatric Uses of Medical Devices Guidance for Industry …
It's time to fast track innovation in medical devices for children
- https://www.statnews.com/2021/02/11/medical-devices-children-fast-tracking-innovation/
- medical devices February 12, 2021 at 3:04 pm Another area of pediatric medical devices that needs improvement is in the treatment of children with the disease of obesity. The children may...
Medical devices and the pediatric population - a head-to …
- https://pubmed.ncbi.nlm.nih.gov/31195845/
- Expert opinion: Children have unique medical device needs; adult devices are often adapted or configured to address these unmet needs. It is important that clinicians, …
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
- Providing Information about Pediatric Uses of Medical Devices: Guidance for Industry and FDA Staff. Final. Issued by: Food and Drug Administration (FDA) Issue …
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 for …
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
- Section 515A (a) of the FD&C Act requires persons who submit certain medical device applications to include, if readily available, a description of any pediatric …
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
- Off-label device use is common in pediatrics because, in many instances, there is no medical or surgical device available that has been approved or cleared …
Leveraging Existing Clinical Data for Extrapolation to …
- https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM444591
- for Extrapolation to Pediatric Uses of Medical Devices . Guidance for Industry and Food and Drug Administration Staff . Document issued on June 21, 2016.
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
- Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a …
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