Zdrowie i gospodarka · 8.03.2001

Medical Devices; Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties; Availability

The Food and Drug Administration (FDA) is announcing the availability of a revision to the guidance document entitled "Guidance for Staff, Industry and Third Parties: Implementation of Third Party Programs Under the FDA Modernization Act of 1997." The revised guidance supersedes the October 30, 1998, guidance. FDA has amended the October 30, 1998, guidance to include criteria for the review of additional moderate risk (class II) devices by accredited persons under the Federal Food, Drug, and Cosmetic Act (the act). The revised guidance will assist those who are interested in participating in the expanded program, which is now in effect.