FDA's pediatric device consortia: National program fosters pediatric medical device development

Pediatrics

Volumn 131, Issue 5, 2013, Pages 981-985

  Ulrich, Linda C ^a   Joseph, Francesca D ^a   Lewis, Debra Y ^a   Koenig, Robert L ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Medical devices; Pediatric device consortia grant program; Pediatric medical device safety and improvement act; Pediatrics

Indexed keywords

ARTICLE; CLINICAL EFFECTIVENESS; DEVICE APPROVAL; DEVICE SAFETY; FOOD AND DRUG ADMINISTRATION; FUNDING; GOVERNMENT; HUMAN; INDUSTRY; INVESTMENT; MEDICAL DEVICE; MEDICAL DEVICE REGULATION; PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007; PEDIATRICS; PRIORITY JOURNAL;

MEDICAL DEVICES; PEDIATRIC DEVICE CONSORTIA GRANT PROGRAM; PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT; PEDIATRICS;

CHILD; CHILD, PRESCHOOL; EQUIPMENT AND SUPPLIES; EQUIPMENT DESIGN; EQUIPMENT SAFETY; FEMALE; HUMANS; INFANT; MALE; NATIONAL HEALTH PROGRAMS; PEDIATRICS; PRODUCT SURVEILLANCE, POSTMARKETING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84877011852     PISSN: 00314005     EISSN: 10984275     Source Type: Journal    
DOI: 10.1542/peds.2012-1534     Document Type: Article

References (7)

1. US Food and Drug Administration. Report to Congress: barriers to the availability of medical devices intended for the treatment or diagnosis of diseases and conditions that affect children (2004, October). Available at: www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ucm135105.htm
2. Sutherell JS, Hirsch R, Beekman RH III. Pediatric interventional cardiology in the United States is dependent on the off-label use of medical devices. Congenit Heart Dis. 2010;5(1):2-7
3. Beekman RH III, Duncan BW, Hagler DJ, et al; Workgroup on Pediatric Cardiac Devices, Section on Cardiology and Cardiac Surgery, American Academy of Pediatrics. Pathways to approval of pediatric cardiac devices in the United States: challenges and solutions. Pediatrics. 2009;124(1):e155-e162
4. Food and Drug Administration Amendments Act of 2007 (FDAAA), §305, Public Law No. 110-85 (2007)
5. Field MJ, Tilson H. The Institute of Medicine Report on Safe Medical Devices for Children. Washington, DC: The National Academies Press; 2006
6. US Government Accountability Office. Report to congressional committees "Pediatric Medical Devices - Provisions Support Development, but Better Data Needed for Required Reporting" (2011, November). Publication GAO-12-225.
7. Feigal D. CDRH vision - total product lifecycle. 2002. Available at: www.fda.gov/ohrms/dockets/ac/01/slides/3799s1-11-Feigal/sld002.htm