The QMN Weekly Bulletin
Medical Devices / Regulatory Affairs / Inspections and Audits

FDA to Specialize Compliance Teams, Cites Increasing Complexity of Devices

Feb. 14, 2014

The FDA will create a device-only enforcement unit that promises more consistent inspections and enforcement decisions with fewer bureaucratic hurdles for investigators to issue warning letters.

Under a reorganization announced Feb. 4, the agency will create specialized teams that will organize regulatory and compliance programs around individual product types such as medical devices, medicines and food. In addition, the FDA promises a streamlined review process for approving enforcement actions.

Commissioner Margaret Hamburg detailed the plan in a memo to agency staff, and FDA officials emphasized that the move is not aimed at cutting costs across the agency. Rather, the agency hopes the reorganization will allow it to respond more quickly to public health threats and target its inspection resources more efficiently.

In justifying the move, Hamburg cited the increasing complexity of medical devices, saying sub-specialists may be needed “to carry out effective oversight of a manufacturer.”

FDA spokesman Stephen King said all agency investigators, compliance officers, import reviewers, laboratory personnel and managers “will begin a transition to become more specialized in a particular regulatory program area.”

The agency’s 26 global districts will remain in place, but their organizational structure will change, King said, declining to give specifics. Meanwhile, ORA’s structure will become more closely aligned with the centers.

Howard Sklamberg, director of the CDER’s Office of Compliance, said Feb. 4 the reorganizationwon’t necessarily increase or reduce the number of warning letters issued. But it will remove bureaucratic layers from the decisionmaking process about which violations to pursue. It also will create investigators qualified to deal with increasingly complex devices and drugs.

The goal is to “heighten the technical expertise throughout the agency, increase and improve communications internally [and] make it easier for folks to interact with us,” Sklamberg said at a Tuesday meeting of the Alliance for a Stronger FDA in Washington, D.C.

The memo also outlines plans to increase laboratory specialization and improve the current laboratory configuration and to enhance training and competency requirements, certification, qualification and accreditation processes for staff.

The next step is that each center director will create an action plan to flesh out the details of the reorganization, with action plans finalized by Oct. 1, the memo reads.

Are your devices growing more and more complex by the year? Either way, you’re going to be subject to the FDA’s ever-growing compliance requirements. Sign up for FDA Compliance Boot Camp 2014 to make sure that you’re prepared the next time the agency rings your doorbell.