The Office of Compliance plans to move “from a product-based structure . . . to a function-based structure.” At the moment, the Division of Enforcement A and Division of Enforcement B divide enforcement responsibilities by product type. Two new divisions will replace them:
- the Division for Premarket and Labeling Compliance, which will be tasked with ensuring device manufacturers fulfill premarket approval and clearance requirements and comply with advertising, promotion, and labeling requirements; and
- the Division of Manufacturing Quality, which will review inspections within the U.S., classify recalls, and develop policy on quality issues.
FDA hopes the changes will enable the Office to better oversee compliance with premarket clearance and approval requirements and advertising and promotional requirements. The agency views these areas as “historically underserved” due to the Office’s focus on quality issues.
In particular, FDA plans to be “more intentional” in its oversight of advertising and promotional activities and to increase headcount devoted to monitoring industry compliance (only two staffers are currently dedicated to promotional compliance). The agency also hopes the new division will address compliance challenges resulting from the less developed regulatory framework for device promotion, in comparison to the framework for drug promotion, and the increased use of social media as a promotional tool.
In addition, recognizing that a significant amount of device manufacturing occurs in other countries, the Office of Compliance will also add a new Division of International Compliance Operations, which will have overseas manufacturing quality functions. The new division will supervise “programs intended to increase FDA’s global presence,” e.g., the medical device single-audit program (which permits FDA-recognized auditing organizations to perform foreign audits).
The current Division of Risk Management Operations will not undergo significant changes but will be called the Division of Analysis and Program Operations. The current Division of Bioresearch Monitoring will remain as is.