Increased Global Focus in FDA Device Compliance Office Restructure

The FDA has created a new Division of International Compliance Operations to oversee inspections of foreign devicemakers and the international audit program. The move, part of a reorganization of the device center’s compliance office, underscores the agency’s commitment to expanding its overseas enforcement footprint.

The agency has yet to appoint a director for the new division.

The restructure also adds a Division of Premarket and Labeling Compliance. It will enforce premarket clearance and approval requirements, in addition to monitoring labeling, promotional and advertising concerns. The division is also charged with responding to high-priority public health concerns, such as fraudulent devices marketed during a pandemic. Stacie Bilek, previously chief of the Division of Enforcement A, will lead the premarket and labeling division.

Other divisions in the Center for Devices and Radiological Health’s Office of Compliance are:

• Division of Analysis and Program Operations. This division analyzes data, develops policy, manages establishment registration and listing, supports recalls and facility inspections, and works with the Office of Regulatory Affairs on inspection planning. It is headed by Ann Ferriter, who directed the Division of Risk Management Operations under the old system;

• Division of Bioresearch Monitoring. This division — the only one whose name carries over from the old structure — provides oversight of clinical trials and coordinates inspections of regulated parties. Its director, Jim Saviola, remains the same; and

• Division of Manufacturing and Quality. Domestic enforcement activities and most recalls fall under the jurisdiction of this division, which also plays a role in reviewing the manufacturing sections of premarket submissions. Bill MacFarland, previously director of the Division of Enforcement B, is leading this unit.

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