The U.S. FDA’s newest draft guidance for dealing with medical product misinformation might seem to signal a cooperative attitude toward misinformation on the agency’s part, but regulatory attorney Daniel Kracov told BioWorld that the disincentives for doing so might still outweigh the incentives despite the reworked draft guidance.
The U.S. FDA posted another early advisory, this time for the Mini PCNL devices by Trokamed GmbH. The agency noted that these devices should not be used for suction and irrigation of surgical sites, a use for which the device was not cleared in the first place.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Axena, Eisai, Flomics, Fujirebio, H.U. Group, Lucid, Oncodia, Renavaro, Roivios, Singular Genomics.
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