On November 18th, 2013 the Food and Drug Administration (FDA) announced that it restructured the Center for Devices and Radiological Health’s (CDRH) Office of Compliance (OC). In the announcement, the agency stated that the reorganization “reflects CDRH’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.”
Due to the restructuring, CDRH’s OC is now organized into a front office staffed by the Office Director and two Deputy Office Directors, and five divisions:
- Division of Analysis and Program Operations (DAPO), which will handle establishment registration and listing, field inspections, and recalls;
- Division of Bioresearch Monitoring (DBM), which will oversee clinical investigations, nonclinical good laboratory practice, and institutional review boards (IRBs) in support of the premarket review program;
- Division of International Compliance Operations (DICO), which will lead on issues relating to foreign device manufacturers, imports, and exports, and also oversee an international audit program;
- Division of Manufacturing and Quality (DMQ), which will focus on domestic enforcement activities and recalls related to device quality and safety, and reviews of premarket approval application manufacturing sections, site change supplements, and signals and complaints related to product quality; and
- Division of Premarket and Labeling Compliance (DPLC), which will enforce requirements regarding premarket clearance and approval, labeling, and advertising.
Each division has a number of sub-branches. Previously, CDRH had the following: a Program Management Officer, Quality Management Staff, Division of Risk Management Operations, Field Programs Branch, Regulatory Policy and Systems Branch, Recall Branch, Division of Biosearch Monitoring, and Division of Enforcement. The Division of Enforcement was divided into further branches based on the type of device. For example, there was a separate branch for dental, ENT and ophthalmic devices and a separate branch covering general hospital devices.
More information about the reorganization can be found here.1