Devices

CDRH Wants Proposals on Device Learning Site Visits

CDRH is soliciting proposals for medical device site visits that can be accommodated in person or virtually as part of its Experiential Learning Program. In addition, the Center encourages proposals addressing patient engagement as a supplemental topic to the current observance of operations in the areas of research, device development, insurance coverage decision-making and assessments.

The program is described as a collaborative approach to closing the knowledge gap between emerging and innovative technology and the pre-market review of the resulting medical devices. “Because technology continuously evolves, it is essential that CDRH review staff are aware of and understand how medical devices are developed, clinically tested, manufactured, and used,” a CDRH notice says.“This program is a collaborative effort to enhance communication and facilitation of the premarket review process. CDRH is committed to understanding current industry practices, innovative technologies, regulatory impacts and needs, and how patient perspective and quality systems management advances the development and evaluation of innovative devices and monitor the performance of marketed devices.”

Additionally, CDRH says the training visits are not intended for the agency to inspect, assess, judge, or perform a regulatory function (for example, compliance inspections).

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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