510(k). Automatic Class III designation (de novo classification) The Food and Drug Administration Modernization Act of 1997 created section 513(f)(2) of the FD&C Act, which obligated the FDA to establish a risk-based regulatory system for medical devices. As a result, the FDA established a de novo pathway for devices that would automatically be classified as Class III because there was no already-existing device that could be used a predicate for a 510k submission, but for which general controls or general and special controls could provide a reasonable assurance of safety and effectiveness. Related legislation The Wheeler-Lea Act, passed in 1938, granted the Federal Trade Commission the authority to oversee advertising of all products regulated by FDA, other than prescription drugs. Significant amendments and related laws Descriptions of these can be found at the FDA's web site. Amendments: Durham-Humphrey Amendment, Public Law (PL) 82–215 (October 26, 1951) created prescription-only status for some drugs Drug Efficacy Amendment ("Kefauver Harris Amendment") PL 87–781 (October 10, 1962) Vitamin-Mineral Amendment ("Proxmire Amendment") (April 22, 1976) prohibited the FDA from establishing standards to limit the potency of vitamins and minerals in food supplements or regulating them as drugs based solely on their potency. Drug Abuse Control Amendments of 1965 Medical Device Amendments of 1976 PL 94–295 (May 28, 1976) Infant Formula Act of 1980, PL 96–359 (October 26, 1980) Orphan Drug Act, PL 97–414 (January 4, 1983) Drug Price Competition and Patent Term Restoration Act of 1984, PL 98–417 (aka Hatch-Waxman) (September 24, 1984) Prescription Drug Marketing Act of 1987, PL 100–293 (August 18, 1988) Generic Animal Drug and Patent Term Restoration Act of 1988, PL 100–670 (November 16, 1988) Nutrition Labeling and Education Act of 1990, PL 101–535 (November 8, 1990) Safe Medical Device Amendments of 1990, PL 101–629 (November 28, 1990) Medical Device Amendments of 1992, PL 102–300 (June 16, 1992) Prescription Drug User Fee Act (PDUFA) of 1992, PL 102–571 (October 29, 1992) Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994, PL 103–396 (October 22, 1994) Dietary Supplement Health And Education Act of 1994, PL 103–417 (October 25, 1994) Food Quality Protection Act of 1996, PL 104–170 (August 3, 1996) Animal Drug Availability Act of 1996, PL 104–250 (October 9, 1996) Best Pharmaceuticals for Children Act, PL 107–109 (January 4, 2002) Medical Device User Fee and Modernization Act (MDUFMA) of 2002, PL 107–250 (October 26, 2002) Animal Drug User Fee Act of