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U.S. Department of Health and Human Services

Medical Devices

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Guidance for Testing MR Interaction with Aneurysm Clips, Draft Document

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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.

This draft document was released for comment on May 22, 1996. Comments will still be accepted and should be submitted to Nada Hanafi, HFZ-450, Office of Device Evaluation, 9200 Corporate Blvd., Rockville, MD 20850. For questions regarding this draft document, contact Nada Hanafi at 240-276-3600.