Pediatric Medical Device Safety And Improvement Act Of 2007

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S.830 - Pediatric Medical Device Safety and …

https://www.congress.gov/bill/110th-congress/senate-bill/830

Pediatric Medical Device Safety and Improvement Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for the approval of a medical device or a product development protocol to include: (1) a description of any …

Public Law 110–85 110th Congress An Act

https://www.congress.gov/110/plaws/publ85/PLAW-110publ85.pdf

TITLE III—PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007 Sec. 301. Short title. Sec. 302. Tracking pediatric device approvals. Sec. 303. …

Popular Name: Pediatric Medical Device Safety and …

https://uscode.house.gov/view.xhtml?req=21&f=treesort&num=40568&edition=prelim

Pediatric Medical Device Safety and Improvement Act of 2007 [Print] [Print selection] [OLRC Home] Help *Public Laws 117-264 through 117-362 have been enacted, but …

TOPN: Pediatric Medical Device Safety and …

https://www.law.cornell.edu/topn/pediatric_medical_device_safety_and_improvement_act_of_2007

Finally, acts may be referred to by a different name, or may have been …

FDAAA Implementation – Highlights One Year After …

https://www.fda.gov/regulatory-information/food-and-drug-administration-amendments-act-fdaaa-2007/fdaaa-implementation-highlights-one-year-after-enactment

S. 830 (110 th ): Pediatric Medical Device Safety and …

https://www.govtrack.us/congress/bills/110/s830/summary

Pediatric Medical Device Safety and Improvement Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for the approval of a …

Encouraging research and development of pediatric …

https://pubmed.ncbi.nlm.nih.gov/19999642/

Abstract. In September 2007, Congress passed the Food and Drug Administration Amendments Act of 2007 (FDAAA). Title III of the FDAAA, the Pediatric Medical Safety …

AAP brings need for pediatric medical devices to forefront

https://publications.aap.org/aapnews/news/6524/AAP-brings-need-for-pediatric-medical-devices-to

The AAP-championed Pediatric Medical Device Safety and Improvement Act of 2007 assisted development by improving device tracking, creating an incentive for …

Pediatric Medical Devices Safety and Improvement …

https://dash.harvard.edu/bitstream/handle/1/9453696/Esther%20Warshauer-Baker%20course%20and%203L%20paper%20EWB.pdf?sequence=1

Amendments Act of 2007. Title III of that law, the Pediatric Medical Safety and Improvement Act, created new incentives, mandates, FDA authority, and funding with the aim of …

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.

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