Federal regulation of medical devices began in 1976 with the signing of the Medical Device Amendments to the Food, Drug and Cosmetic Act. For the purpose of regulating medical devices, the Food and Drug Administration is divided into various divisions and branches, including the Office of Device Evaluation. The evolution of the Food and Drug Administration's regulations of laparoscopic devices is described. Also described is the technology of laparoscopic surgical devices and how they are regulated by the Office of Device Evaluation. Trends towards the future of laparoscopic devices, and their regulation, are reviewed.
Get full access to this article
View all access options for this article.
References
1.
1. Dent TL . Training, credentialling, and granting of clinical privileges for laparoscopic general surgery . Am J Surg161: 399-403 , 1991.
2.
2. Gadacz TR , Talamini MA . Traditional versus laparoscopic cholecystectomy . Am J Surg161: 336-338 , 1991.
3.
3. Zucker KA . Training issues [editorial] . Surg Laparosc Endosc2: 187-187 , 1992.
4.
4. Rock JA , Warshaw JR . The history and future of operative laparoscopy . Am J Obstet Gynecol170: 7-11 , 1994.
5.
5. Gates EA . New surgical procedures: Can our patients benefit while we learn?Am J Obstet Gynecol176: 1293-1299 , 1997.
6.
6. Reznick R . Let's not forget that CME has an “E.”Foc Surg Ed17: 1-2 , 1999.
7.
7. Morino M , Festa V , Garrone C . Survey on Torino courses. The impact of a two-day practical course on apprenticeship and diffusion of laparoscopic cholecystecomy in Italy . Surg Endosoc9: 46-48 , 1995.
8.
8. Wright D , O'Dwyer PJ . The learning curve for laparoscopic hernia repair . Semin Laparosc Surg5: 227-232 , 1998.
