Not up on the US medical device market? Here’s what’s happened in 2016 so far

By Stewart Eisenhart, Emergo Group

US regulators have warranted close attention from the QA/RA Blog since 2016 began. Using new 510(k) performance data from the FDA, Emergo has conducted an updated analysis of medical device clearance timeframes and related issues, as well as covered new agency initiatives for human factors and its Unique Device Identification (UDI) system.

Major US FDA-related news over the first several weeks of 2016 includes:

• The agency has begun accepting Global Unique Device Identification Database (GUDID) account requests from Class II device labelers
• Device types for which FDA reviewers require human factors testing data have been specified.
• An Emergo analysis of FDA 510(k) data shows changes in where premarket notifications are coming from, and in terms of how long it takes to clear a device for sale in the US.
• A MDUFA III-commissioned performance report commends the FDA for its efforts to improve premarket review processes.
• US Congressional proposals to revamp FDA device premarket reviews and clinical trial requirements are gaining traction.
• Which regions of the US foster the most medical device industry activity? An Emergo analysis identifies metropolitan areas most attractive to device manufacturers.
• Coverage organizations’ input sought by the FDA for medical device clinical trial designs, with implications for insurance and reimbursement.

For additional information on US medical device regulations, see our whitepaper on FDA device registration and our video overview on US medical device registration and approval.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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