The Office of Compliance (OC) mission is to protect and promote public health by evaluating, enhancing, and ensuring compliance with medical device laws, resulting in the availability of high-quality medical devices. OC’s vision is to take actions that enable maximum device safety and effectiveness.
OC takes targeted, risk‐based compliance actions that address significant violations of device-related laws. We also promote public health by facilitating innovation and fostering a culture of quality within an ever‐expanding global medical device market.
OC is structured to address the demands of medical device oversight in the areas of quality and product integrity. OC has a front office and five divisions. An overview of each division follows:
Division of Analysis and Program Operations (DAPO) analyzes data, develops policy, drafts processes, collaborates with FDA’s Office of Regulatory Affairs (ORA) on inspection planning and assignments, runs the establishment registration and listing program, and supports recall processing and establishment inspection reviews.
Division of Bioresearch Monitoring (DBM) provides regulatory oversight of medical device clinical investigations, nonclinical good laboratory practice, and institutional review boards in support of the premarket review program. The division coordinates and reviews monitoring inspections of regulated parties and takes necessary action when appropriate. It also investigates and coordinates allegations of research misconduct.
Division of International Compliance Operations (DICO) focuses on foreign device manufacturer and importer assessment; international audit program, compliance policy, and guidance development; export operations and policy; and stakeholder communication and outreach.
Division of Manufacturing and Quality (DMQ) leads domestic enforcement activities and recalls related to device quality and safety, and reviews premarket approval application manufacturing sections, site change supplements, and signals and complaints related to product quality. This division is also the lead on device quality policy.
Division of Premarket and Labeling Compliance (DPLC) enforces premarket clearance and approval requirements, as well as labeling and promotion and advertising requirements for medical devices. This division engages in surveillance of industry practices and responds to urgent or high‐priority public health concerns, such as fraudulent devices marketed during a pandemic.