CDRH Proposes Organizational Overhaul to Embrace Total Life Cycle Approach


Posted February 27, 2018

With a focus on agility, the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is proposing a major reorganization intended to promote a total product life cycle approach to regulation. The reorganization will affect the Office of Device Evaluation, the Office of Compliance, the Office of Surveillance and Biometrics, and the Office of In Vitro Diagnostics and Radiological Health.

“We want to focus our organization around the big picture and holistic regulation so we are able to meet our patient-centric goals,” said Erin Keith, director of CDRH’s Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices. “We want an agile infrastructure that lets us adapt to future organizational, regulatory, or scientific needs. We want to minimize the layers of review needed to make decisions. And we want our staff to embrace the total product life cycle view of devices while making decisions.”

Keith, who is the total product life cycle project lead, is planning to introduce these changes to the medical device industry in March at AAMI’s International Conference on Medical Device Standards and Regulations.

Overall, these changes will include:

  • The creation of seven product-focused offices.
  • A single management chain covering the entire product life cycle—premarket, postmarket, and compliance—“making cross-program decisions easier to make and implement,” according to Keith.
  • Joint responsibility for the management team for performance across a division and an office.
  • An increased emphasis on professional development that is “baked into the structure.”

The idea of incorporating a total product life cycle approach into CDRH’s activities is not new. In 2002, the center created a product-focused office responsible for the end-to-end product review program and activities for in vitro diagnostic products.

“We’ve had that model going for over a decade now,” Keith explained. “We think that it works well and that it’s effective to have people who are aware of what’s going on in the premarket cycle be working with or be part of the group that is working in the postmarket cycle. That way, information flows back and forth, and we have a bigger picture of what’s going on and make more informed decisions about the activities that we do throughout the spectrum of the device’s life cycle.”

Although plans for the reorganization have been developed, implementation is not expected to begin until later this year, according to Keith.

“We have somewhat limited control over that because we have to wait for approval,” she said. Approval will have to come from the FDA and the Department of Health and Human Services, and Congress will have an opportunity to comment.

Once implementation begins, Keith does not anticipate industry seeing much of a difference in how their products are evaluated.

“We want it to be a smooth transition for them,” Keith said. “There will be some changes because there will be some shuffling of some of the branches, so we are aware that people will need a guide to help them understand where to go, but we think, in the long run, having this organizational structure will make it easier for industry, patients, the medical community, and the rest of our stakeholders to find the group that they need to talk to and resolve their issues faster.”

The International Conference on Medical Device Standards and Regulations will be held March 22–23 at the Crystal Gateway Marriott in Arlington, VA. The full conference schedule and registration details are available at www.aami.org/isc.