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Safety + Innovation: FDA’s Medical Device Safety Action Plan outlines measures to improve safety of medical devices & spur innovation in the development of critical devices that improve the lives of patients go.usa.gov/xQjmz

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3:48 PM · Apr 17, 2018

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The vision of @SGottliebFDA to jointly facilitiate innovation and improve #ptsafety is admirable. Making progress on both is possible, and both rely on better, more efficient ways to collect data on product safety, effectivness & quality. That sentiment weaves through the plan 2/

Use of device IDs serve as a key thread tying the plan together. However, creation of UDIs is not enough. They need to be integrated into different data systems to reach their potential 3/

“UDI provides a standard and clear way to document device use, including in electronic health records, clinical information systems, claims data sources, and registries.” Progress being made here. Need continued suport from

@US_FDA

@CMSGov

to advance device IDs in claims 4/

also described as a cornerstone to a robust safety network, to link data sources and leverage the strengths of each data source to address deficiencies in others FDA seeking to use $ in President's Budget for "New Medical Data Enterprise" to support NEST 5/

FDA exploring the limits of its current authorities, and whether new authorities needed to simultaneously promote safety & innovation 6/

#CyberSecurity an emerging area where several opportunities are being explored, including enhancing patching requirements, information submitted in premarket review & disclosures of vulnerabilities 7/

FDA calls out the safety risks of networked devices if hacked. E.g. vulnerability in a device could serve as a gateway in to the network and, for example, shut down the #healthIT systems 8/

FDA pitches reorganization of CDRH to merge premarket/postmarket responsibilities, and regroup in to total product life cycle teams according to device type 9/