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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.

We are withdrawing this guidance because its discussion regarding silicone gel breast implant clinical studies is outdated. For updated clinical data information, please refer to our breast implant guidance dated August 13, 2001 at http://www.fda.gov/cdrh/ode/guidance/1354.html

Updated 3/18/02

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Center for Devices and Radiological Health / CDRH