Seminars in Pediatric Surgery
Volume 15, Issue 4 , Pages 293-301 , November 2006

Making sense of the Food and Drug Administration

  • Jessica Anne Connor, BS

      Affiliations

    • Corresponding Author InformationAddress reprint requests and correspondence: Jessica Anne Connor, BS, Stanford University Medical Center, Lucile Packard Children’s Hospital, Biodesign Surgical Innovation Program, 780 Welch Road, Suite 206, Stanford, CA 94305.

References 

  1. Spurgin EA. Planning effective interaction with FDA. Diabetes Technol Ther. 2004;6(6):770–775
  2. Kaplan AV, Baim DS, Smith JJ, et al. Medical device development: from prototype to regulatory approval. Circulation. 2004;109:3068–3072
  3. Maisel WH. Medical device regulation: an introduction for the practicing physician. Ann Intern Med. 2004;140(4):296–302
  4. Guidance for industry and FDA staff: premarket assessment of pediatric medical devices. Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration; 2004;Available from: http://www.fda.gov/cdrh/mdufma/guidance/1220.html. Accessed April 30, 2006.
  5. An overview of FDA: protecting consumers, protecting public health. Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration; 2002;Available from: http://www.fda.gov/oc/opacom/fda101/sld001.html. Accessed April 30, 2006.
  6. Saviola J. The FDA’s role in medical device clinical studies of human subjects. J Neural Eng. 2005;2:S1–S4
  7. Rados C. Medical device and radiological health regulations come of age. FDA Consumer. 2006;59–65January/February
  8. 21 U.S.C. §321.
  9. Kessler L, Richter K. Technology assessment of medical devices at the center for devices and radiological health. Am J Manag Care. 1998;4:SP129–SP135
  10. Hackett JL, Gutman SI. Introduction to the Food and Drug Administration (FDA) regulatory process. J Proteome Res. 2005;4(4):1110–1113
  11. Device classes. Rockville, MD: U.S. Department of Health and Human Services Food and Drug Administration; 2002;Available from: http://www.fda.gov/cdrh/devadvice/3132.html#class_1. Accessed April 30, 2006.
  12. 21 U.S.C. §360(c).
  13. General controls for medical devices. Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration; 2002;Available from: http://www.fda.gov/cdrh/devadvice/363.html. Accessed April 30, 2006.
  14. Munzer R. U.S. medical device classification. IEEE Eng Med Biol Mag. 2004;207–298
  15. Kaplan AV, Harvey ED, Kuntz RE, et al. Humanitarian use devices/humanitarian use device exemptions in cardiovascular medicine. Circulation. 2005;112:2883–2886
  16. Rinaldi JE, Chen EA, Berman M. Pediatric circulatory support: an FDA perspective. ASAIO J. 2005;51:533–535
  17. Listing of CDRH humanitarian device exemption summaries of safety and possible benefit. Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration; 1995;Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfHDE/HDEInformation.cfm. Accessed April 30, 2006.
  18. McKneally MF, Daar AS. Introducing new technologies: protecting subjects of surgical innovation and research. World J Surg. 2003;27:903–935
  19. Caldwell PHY, Murphy SB, Butow PN. Clinical trials in children. Lancet. 2004;364:803–811
  20. Steinbrook R. Testing medications in children. N Engl J Med. 2002;347(18):1462–1470
  21. 21 CFR Part 812.
  22. Significant risk and nonsignificant risk medical device studies. Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration; 1995;Available from: http://www.fda.gov/cdrh/d861.html. Accessed April 30, 2006.
  23. 21 CFR 812.3(i).
  24. Determination of intended use for 510(k) Devices: guidance for CDRH staff (update to K98-1). Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration; 2002;Available from: http://www.fda.gov/cdrh/ode/guidance/857.pdf. Accessed April 30, 2006.

PII: S1055-8586(06)00057-6

doi: 10.1053/j.sempedsurg.2006.07.009

Seminars in Pediatric Surgery
Volume 15, Issue 4 , Pages 293-301 , November 2006