FDA prioritizes an A-list and B-list for the guidance documents it plans to publish in FY 2017.
Highlights include leveraging big data, streamlining clinical trial design, reducing healthcare-associated infections and toughening up on cybersecurity.
An upcoming conference brings together FDA and key industry stakeholders to discuss best practices in health hazard evaluations and global recalls.
The agency has posted new education modules about the unique device identification rule.
The agency is creating a virtual center of excellence to expedite the development of combination products.
The agency calls out specific devices that should include human factors data in premarket submissions, along with recommendations for combination products.
From human factors to laboratory developed tests to medical device reporting, CDRH has ambitious plans for 2016.
Almost half as many devices were recalled this year compared to 2014.
The agency will bring together major stakeholders to discuss challenges in medical device cybersecurity.
When preparing a regulatory submission, there are a couple of critical elements to consider.