美国FDA 指导原则 卫生保健专业人员使用的夏普容器和驱逐舰的制造商和初始分销商 英文原版.pdfVIP

This guidance was written prior to the February 27, 1997 implementation of FDAs Good Guidance Practices, GGPs. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance willbe up dated in the next revision to include the standard elemnts of GGPs . DEPARTMENT OF HEALTH HUMAN SERVICES Public Health Secvice Food and Drug Administration Center for Devices and Radiological Health FEB 3 1994 2098 Gaither Road Rockville M D 20850 TO:MANUFACTURERS AND INITIAL DISTRIBUTORS OF SHARPS CONTAINERS AND DESTROYERS USED BY HEALTH CARE PROFESSIONALS: The purpose of this letter is to clarify the regulatory status of devices which serve as Sharps Containers and/or Sharps Destroyers (sharpsdevices). These products are devices as that term is defined by Section 201(h) of the Federal Food, Drug, and C~smetic Act (theAct). In the past, FDA has exercised enforcement discretion, and has not actively enforced marketing clearance, registration and listing, and manufacturing requirements for these devices. This document shall serve to clarify all past correspondence and outline all requirements which=need to be complied with to lawfully market these devices. Because of increasing concern about transmission of disease associated with needle sticks, e.g., HIV, Hepatitis B, and other blood born agents, we are exercising our discretion to now require manufacturers and initial distributors of sharps devices t