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BioWorld - Friday, February 13, 2026
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Home » FDA, MITA have different views of regulatory compliance liability for device servicers
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FDA, MITA have different views of regulatory compliance liability for device servicers

July 27, 2021
By Mark McCarty
The FDA’s July 27 webinar on medical device servicing and remanufacturing lent some clarity to the terms of a recent draft guidance on the subject, but there are several overarching policy concerns. The FDA’s Joshua Silverstein said on the webinar that the agency sees servicing as a type of manufacturing, a view that is contradicted by the Medical Imaging & Technology Alliance, which indicated earlier this year that third-party servicers are probably not subject to the regulations applied to manufacturers.
Medical technology Regulatory Medical devices U.S. FDA

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