FDA's Strategy For Interoperable Medical Device Regulation

Law360, New York (February 4, 2016, 12:15 PM EST) -- Mark Mansour

Angela E. Giancarlo

Christopher M. Mikson This week, the Food and Drug Administration issued draft guidance entitled Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices. The FDA issues such documents to provide the agency's "current thinking" on a matter of concern to regulators and stakeholders. This particular guidance provides FDA's views on issues that device makers should consider when designing interoperable medical devices. In addition, FDA's draft guidance discusses how device makers should prepare a premarket submission, which is a form of application for permission to market a medical device. Many companies are likely to take an...

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