Devices

CDRH Announces Organizational Changes

CDRH is announcing new organizational changes to help the Center meet commitments under the Medical Device User Fee Amendments reauthorization and other strategic priorities. For example, CDRH is elevating the Office of Communication and Education into a super office called “Office of Communication, Information Disclosure, Training, and Education (OCITE)” and creating a new Division of Digital Communication and Marketing. The elevated status will “allow the Center to assure that information about CDRH programs is accurately and readily shared with our customers, including FDA employees, patients, health care professionals, and regulated industry,” CDRH director Jeff Shuren is quoted in a release as saying. “The new Super Office will be responsible for delivering clear, meaningful, insights-based communications, education, and disclosures about medical devices and radiation-emitting products.”

OCITE will house two new sub-offices — the Office of Communication and Content Development and the Office of Training and Education — and it will create a new Division of Digital Communication and Marketing. “This new structure will provide increased organizational flexibility and consistency, and position CDRH to plan for and meet current and future needs more effectively,” Shuren says.

Additionally, Shuren says the Center is making structural changes within the Office of Product Evaluation and Quality in both the Office of Clinical Evidence and Analysis (OCEA) and the Office of Health Technology 4 (OHT4): Surgical and Infection Control Devices to “help improve efficiencies within the offices and better meet the needs of our customers.” OCEA provides policy and program support on clinical trials, biostatistics, real-world evidence, epidemiological analysis and outreach and collaboration with hospitals and other external stakeholders. OHT4 is responsible for the review of surgical and infection control medical devices.

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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