Overhaul of CDRH's Office of Compliance Creates Six-Division Structure, New Advertising Office
The Center for Devices and Radiological Health (CDRH), the US Food and Drug Administration's (FDA) medical device regulation and compliance-enforcement body, has announced that it has reorganized its Office of Compliance (OC) with the stated goal of better aligning its resources to its mission.
The OC, led by director Steven Silverman, is now set to include six divisions:
- a front office containing its leadership staff, including Silverman, Deputy Office Director for Medical Affairs Kimber Richter, and Deputy Office Director for Regulatory Affairs Jan Welch
- Division of Analysis and Program Operations (DAPO), charged with analyzing data, developing policy and working with FDA's Office of Regulatory Affairs (ORA) to register and inspect facilities, as well as processing recalls
- Division director: Ann Ferriter
- Division of Bioresearch Monitoring (DBM), charged with overseeing clinical investigations, nonclinical regulatory compliance and institutional review board.
- Division director: Jim Saviola
- Division of International Compliance Operations (DICO), charged with assessing the regulatory compliance of foreign device manufacturers and entities with US policies, particularly at the point of a product's import into the US
- Division director: Currently vacant
- Division of Manufacturing and Quality (DMQ), charged with leading domestic enforcement and recall activities, reviewing premarket approval applications' manufacturing sections and site change supplements, and taking the lead on matters of device quality policy
- Division director:Bill MacFarland
- Division of Premarket and Labeling Compliance (DPLC), charged with enforcing advertising, promotion and labeling (APL) regulations
- Division director: Stacie Bilek
The divisions all have a number of sub-branches, with DAPO and DMQ having as many as four each.
The move is particularly notable in that it includes a new division (DPLC) for APL compliance. As recently as October 2013, CDRH's advertising review staff within the Advertising and Promotional Labeling Branch (APLB) was bare-bones in comparison to drug regulators' Office of Prescription Drug Promotion (OPDP), which has a staff of nearly 80.
The new structure would provide the APL for a vehicle for growth-the current office only includes two promotional review staff-and could foreshadow a greater focus on medical device advertising enforcement by the agency.
To FDA, however, the changes reflect a more fundamental commitment. "This reorganization reflects the Center's commitment to assure compliance with device-related laws and safeguard medical device quality and aligns with CDRH's mission to protect and promote public health by affording patients and healthcare providers timely and continued access to safe, effective, and high-quality medical devices," FDA wrote in a statement to industry.