Devices

CDRH Digital Transformation Initiative Updated

CDRH director Jeffrey Shuren and Office of Product Evaluation and Quality director William Maisel say the Center’s Digital Transformation Initiative is strengthening the premarket review program. Writing in an online FDA Voices post, Shuren and Maisel say that building a robust infrastructure within FDA and efficient external data interfaces with stakeholders are among the top priorities of the agency Technology Modernization Plan.

They say the Digital Transformation Initiative “reflects important near-term actions that FDA is taking to achieve these top priorities and advance FDA’s public health mission, which has been supported and will continue to be supported to a great extent by congressional funding over the next several years.”

The post describes:

the Digital Transformation Initiative’s focus on improving the user experience for customers both internal and external to FDA, enhancing CDRH’s ability to accept, store, analyze, and distribute data, and digitalize CDRH programs and operations;
the customer collaboration portal, a secure Web-based dashboard that displays CDRH progress in reviewing traditional 510(k) submissions;
development of the submission memo and review template (SMART) for 510(k) and de novo reviews to make the administrative aspects of premarket review more efficient and consistent;
the electronic submission template and resource (eSTAR) to enhance the quality of 510(k) submissions for a wide range of medical devices by helping to ensure submitters provide quality, comprehensive data for agency premarket review; and
the new decision management portal to help CDRH staff become more efficient in their day-to-day work.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome