This guidance was written prior to the February 27, 1997 implementation of FDA's Good Guidance Practices, GGP's. 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 will be updated in the next revision to include the standard elements of GGP's.

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The purpose of this letter is to clarify the regulatory status of devices which serve as Sharps Containers and/or Sharps Destroyers (sharps devices). These products are devices as that term is defined by Section 201(h) of the Federal Food, Drug, and CQsmetic Act (the Act). 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.