Guidance Document for Testing Orthopedic Implants with ... | 合法醫療器材資訊網

2018年3月23日—...thatareincontactwithtissueorbonecement(e.g.,porouscoatings)....1997implementationofFDA'sGoodGuidancePractices,GGP's.

Guidance Issuing Office

Center for Devices and Radiological Health

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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 will be updated in the next revision to include the standard elements of GGPs

April 28, 1994

Orthopedic Devices Branch Division of General and Restorative...