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Home » MITA urges FDA to make numerous technical changes to performance draft for MRI coils
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MITA urges FDA to make numerous technical changes to performance draft for MRI coils

Feb. 11, 2020
By Mark McCarty
The Dec. 9, 2019, FDA draft guidance spelling out performance criteria for magnetic resonance coils seemed to take up a relatively simple matter, but industry’s response suggested otherwise. The Medical Imaging & Technology Alliance (MITA) recommended that the agency undertake nearly two dozen changes to the draft, including a change to the title to indicate that the scope of the guidance is limited to receive-only MRI coils.
BioWorld MedTech Regulatory Diagnostics Imaging U.S. FDA

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