Devices

FDA Changes Medical Device Classification Regs

FDA says it is issuing a final rule to amend its regulations governing classification and reclassification of medical devices to conform to changes made in the FDA Safety and Innovation Act (FDASIA). A Federal Register notice says the rule also makes additional changes, unrelated to FDASIA, to update other affected regulations.

“FDA is taking this action to codify the procedures and criteria that apply to the classification and reclassification of medical devices and to provide for classification of devices in the lowest regulatory class consistent with the public health and the statutory scheme for device regulation,” the notice says.

FDASIA amended provisions for reclassification of devices and for requiring PMA applications for preamendments Class 3 devices to change from a rulemaking proceeding to an administrative order process, the notice says. The final rule reflects procedural changes requiring the agency to publish a proposed order before publishing a final order reclassifying a device or requiring a PMA application for a preamendments Class 3 device, to consider any comments on the proposed order, and to hold a device classification panel meeting. It also clarifies the process where reclassification of a postamendments device or a transitional device is initiated by FDA, rather than in response to a petition.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome