This past Monday (November 18), the FDA Center for Devices and Radiological Health (CDRH) launched a new webpage describing the revamped structure of its Office of Compliance (OC). One of the stated goals of the reorganization is to better align OC’s resources to its mission. While the stated goal in and of itself is fairly generic, the new structure (including new divisions) does provide some interesting insight into what CDRH sees as priorities in 2013 and moving forward.
Besides a “front office” featuring Director Steven Silverman and Deputy Directors Kimber Richter (Medical Affairs) and Jan Welch (Regulatory Affairs), OC is now organized into five separate operating divisions:
1. The Division of Analysis and Program Operations (DAPO);
2. The Division of Bioresearch Monitoring (DBM);
3. The Division of International Compliance Operations (DICO);
4. The Division of Manufacturing and Quality (DMQ); and
5. The Division of Premarket and Labelling Compliance (DPLC).
According to CDRH’s webpage, 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.” DAPO has a fairly varied set of responsibilities, including many that are administrative in nature.
DBM “provides regulatory oversight of medical device clinical investigations, nonclinical good laboratory practice, and institutional review boards in support of the premarket review program,” according to CDRH’s webpage. It also “coordinates and reviews monitoring inspections of regulated parties and takes necessary action when appropriate. It also investigates and coordinates allegations of research misconduct.” The division has two separate compliance branches, showing CDRH’s commitment to resources in this area. Oversight in this area appears to be growing and not shrinking. Overall, this division represents FDA’s continuing goal of and focus on ensuring quality clinical trials and the protection of study subjects who participate in such trials. Mentions of good laboratory practices in the division’s description also highlights the recent revitalization of FDA’s focus on good laboratory practices, 21 C.F.R. Part 58, a part of FDA’s regulations that was recently revised, but somewhat forgotten for many years before the revisions.
Per CDRH’s webpage, 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.” DICO is broken into three branches: the Foreign Enforcement Branch; the Import Branch; and the Export Branch. Obviously, in recent years, there has been a growing focus on the quality of foreign-made devices reaching our borders and being placed into commercial distribution. FDA has addressed this growing focus through foreign inspections and increased import scrutiny. The creation of this division signals a continued and possibly growing commitment in this area. As CDRH activity related to international cooperation, especially on the establishment inspection front, grows, so too may the importance of this division.
As for DMQ, the CDRH webpage states that it “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.” This division highlights the significance that CDRH places on the Quality System Regulation (QSR), 21 C.F.R. Part 820, as a primary basis for ensuring safe and effective marketed medical devices. The QSR enumerates good manufacturing practices for medical devices.
Finally, per CDRH’s webpage, 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.” Recently, CDRH’s promotion and advertising policy staff has been very small. The new division could signal this as a growth area for CDRH, with more emphasis on promotion and advertising compliance/enforcement activities.
It will be interesting to see if the restructuring of OC translates into a somewhat changed FDA regulatory landscape for the medical device industry. Moreover, not every reorganization bears fruit for the Agency. Hopefully, this revamping will bear positive results for CDRH.