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Home » Not-so-confidential: Trade groups see disclosure risk in FDA device remanufacturing draft
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Not-so-confidential: Trade groups see disclosure risk in FDA device remanufacturing draft

April 14, 2022
By Mark McCarty
The FDA’s June 2021 draft guidance for remanufacturing of medical devices wades into a highly complicated area of compliance for third-party servicing organizations that may not be familiar with FDA regulations, but the draft has sparked another set of concerns. Two trade associations said the draft would seem to suggest that original equipment manufacturers (OEMs) must disclose confidential trade secrets to give these third parties the information needed to service these devices, a suggestion that both the Medical Device Manufacturers Association (MDMA) and the Advanced Medical Technology Association (AdvaMed) said is clearly out of bounds.
BioWorld MedTech Regulatory U.S. FDA

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