From: Medical Device and Diagnositc Industry
Straight from the headlines to the priority list. CDRH’s FY2016 regulatory science priorities include a few issues that will be familiar to anyone who has kept tabs on FDA headlines this year.
Marie Thibault
This week, CDRH released its top priorities for regulatory science needs. CDRH describes this list as 10 equally important issues that were identified by the Regulatory Science Subcommittee (RSS) of the CDRH Center Science Council. CDRH’s report notes that identifying these priorities “helps the Center address the most important regulatory science gaps or needs.”
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- Leverage “Big Data” for regulatory decision making—CDRH writes that big data brings a tremendous amount of valuable information to the issue of quality, safety, and effectiveness of medical devices and it is important to find ways to gather, store, and analyze the information for this application. One of MD+DI‘s finalists for 2015 Medtech Company of the Year is IBM Watson Health, the masters of big data.
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