References
- Possible Barriers to the Availability of Medical Devices Intended to Treat or Diagnose Diseases and Conditions that Affect Children; Request for Comments. Federal Register. 69 FR 34374 (June 21, 2004).
- 110th U.S. Congress, Congressional Record. 153(110), H1671, 11 July (2007).
- Report to Congress: HHS and FDA’s premarket approval pediatric uses of devices- FY 2008, submitted pursuant to section 515A of The Federal Food, Drug and Cosmetic Act, October (2008).
- Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended to Treat, Diagnose, or Cure, Federal Register, Proposed Rule, 78 FR 11612, 19 February (2013).
- U.S. GAO Report GAO-12–225: pediatric medical devices: provisions support development, but better data needed for required reporting. December (2011).
Websites
- Food and Drug Administration, CDRH guidance, “Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric MedicalDevices.” www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089742.pdf
- Food and Drug Administration, CDRH guidance, “Guidance for Industry and FDA Staff: Pediatric Expertise for Advisory Panels.” www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm082188.pdf
- CDRH’s Compassionate Use Program. www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm051345.htm#compassionateuse
- Medical Device User Fee and Modernization Act of 2002. www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm
- Summary of the Medical Devices Technical Corrections Act of 2004. www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109131.pdf
- Food and Drug Administration Amendments Act of 2007 and Pediatric Medical Device Safety and Improvement Act of 2007. www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/default.htm
- FDA Public Workshop, Pediatric Clinical Trials Workshop: Unmet Needs, Trial Designs & Clinically Meaningful Safety & Effectiveness Outcomes (2009). www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm222293.htm
- FDA Public Workshop, Pediatric Assessments of Neurological and Neurocognitive Function for Cardiovascular Devices (March 25, 2010). www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm199037.htm
- FDA Public Workshop, Using Scientific Research Data to Support Pediatric Medical Device Claims (December 5, 2011). www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm278053.htm
- More information on the FDA Orphan Products Grant Program. www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/WhomtoContactaboutOrphanProductDevelopment/ucm134580.htm
- FDA’s Orphan Products Grant Program Awards for Fiscal year 2013. www.fda.gov/downloads/forindustry/developingproductsforrarediseasesconditions/whomtocontactaboutorphanproductdevelopment/ucm368250.pdf
- Food and Drug Administration Safety and Innovation Act. www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm20027187.htm