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FDA's device law and policy activities from 2020. - Vimarsana News

FDA's device law and policy activities from 2020.

Tuesday, December 15, 2020 What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was thrust into the public eye amidst the COVID-19 pandemic. This was the year many Americans became familiar with lesser-known and niche policies like those governing emergency use authorizations (EUAs) and with the role of FDA in regulating laboratory developed tests (LDTs). The agency also took some flak for seeming to bow to political pre...

Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway - Vimarsana News

Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway

Center for Devices and Radiological Health This guidance provides performance criteria for magnetic resonance (MR) receive-only coils in support of the Safety and Performance Based Pathway. Under this framework, submitters (you) planning to submit a 510(k) using the Safety and Performance Based Pathway for MR receive-only coils will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device. Submit Comments

Source: fda.gov