CDRH Begins Major Reorganization Effort


Posted March 19, 2019

The Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has started implementing a major reorganization intended to make it more agile and focused on a total life cycle approach to managing medical devices. This long-planned reorganization combines several offices dedicated to the regulation of medical devices into one “super office” and establishes two new offices dedicated to policy and innovation.

“Although CDRH has applied a total product life cycle approach to the regulation of devices for many years, the reorganization will enhance communication among CDRH staff and enable more efficient activities across the life cycle from premarket review to postmarket surveillance,” the agency wrote in a statement.

The organizational structure of CDRH will change through the establishment of three new offices, with accompanying changes to management structure.

  1. The Office of Product Evaluation and Quality will be dedicated to medical device oversight throughout the total product life cycle. This new “super office” will consist of product-focused offices and includes CDRH’s current Office of Compliance, Office of Device Evaluation, Office of Surveillance and Biometrics, and Office of In Vitro Diagnostics and Radiological Health.
  2. The Office of Policy will include the Guidance, Legislation, and Special Projects Team and the Regulatory Documents and Special Projects Team.
  3. The Office of Strategic Partnerships and Technological Innovation will combine the Science & Strategic Partnerships, Digital Health, Health Informatics, and Innovation teams.

Although the Office of Communication and Education will remain, CDRH also is combining its internal and external communications staff into a Division of Communication with an Internal Communication Branch.

“After full implementation, the reorganization will integrate CDRH’s premarket and postmarket program functions along product lines, allowing our experts to leverage their knowledge to optimize decision-making across the product life cycle,” the agency wrote. “This type of structure consolidates and integrates many of the current aspects of product review, quality, surveillance and enforcement into a new, team-based approach.”

A phased approach to the reorganization  began this week, with full implementation expected by Sept. 30. During this transition, points of contact with CDRH offices may change, and the center advised industry to check its management directory periodically.

The effects of the CDRH reorganization will be discussed during the upcoming International Conference on Medical Device Standards and Regulations, which is being held April 24–25 in Reston, VA. For more information, visit www.aami.org/InternationalStandards