A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems

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in the next revision to include the standard elements of GGP's DRAFT DOCUMENT This document is being distributed for comment purposes only. CDRH Magnetic Resonance Working Group Draft released for comment on: February 7, 1997 The Federal Register notice reopening the comment period for this document was published May 22, 1997, and extends the comment period to August 20, 1997. Comments and suggestions regarding this draft document should be submitted to Marlene Skopec, Office of Science and Technology, HFZ-133, 12721 Twinbrook Pkwy, Rockville, MD 20852. Comments and suggestions received after August 20, 1997, may not be acted upon by the Agency until the document is next revised or updated. For questions regarding this draft document, contact Marlene Skopec at (301) 443-3840. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Center for Devices and Radiological Health