The QMN Weekly Bulletin
Medical Devices / Regulatory Affairs / Inspections and Audits

CDRH Compliance Office Restructure Puts Quality Ahead of Enforcement: Silverman

Feb. 14, 2014

In deciding to reorganize the Office of Compliance, CDRH made the pragmatic decision to focus its limited resources on encouraging quality rather than on compliance enforcements, OC Director Steve Silverman says.

The logic behind that decision was simple: if the FDA brings an injunction against a devicemaker, other companies might pay attention. But even if the number of injunctions doubled from the current three per year to six, that’s nowhere near enough to change noncompliant practices at the 20,000-odd device companies regulated by the agency, Silverman said. “We want to leave enforcement actions for the outliers,” he added.

Speaking at a Feb. 5 FDAnews webinar, Silverman said, “We understand the reorganization may raise questions, but we’ve tried to be transparent.”

The CDRH Reorganization in November morphed OC’s four divisions into five: the Division of Analysis and Program Operations (DAP); the Division of Manufacturing & Quality (DMQ); the Division of Premarket and Labeling Compliance (DPLC); the Division of International Compliance Operations (DICO); and the Division of Bioresearch Monitoring (DRM). Of these, only DRM survived largely unchanged. OC’s front office handles human resources, budgets and other centralized responsibilities.

The reorganization included creating a “group lead” to oversee discrete issues such as quality systems. This person doesn’t work in compliance on a day-to-day basis, but plays a key role in flagging recurrent manufacturer problems and drafting industry guidance, when needed.

The changes have helped OC get the most out of limited resources, increasing efficiencies and allowing staff to develop deeper expertise in specific areas, Silverman said. That greater expertise allows for enhanced consistency in regulatory decisions, he added.

Several key roles within OC remain unfilled, including the deputy directors of DAP and DICO. Silverman said he hopes to fill these “as soon as possible,” but added that no candidates have been interviewed.

DAP brings a new focus on analytics, which allows the division to provide services throughout the FDA, Silverman explained. A Recall Branch within DAP leads policy discussions over recall classification and is improving the pace of that process, he said. Another DAP unit, the Allegations of Regulatory Misconduct Branch, manages programs that receive, track and evaluate complaints about devices.

Because radiology devices and in vitro diagnostic products are regulated by the Office of In Vitro Diagnostics and Radiological Health, companies that feel OIR and OC have issued conflicting directives should work with OC, OIR and the FDA field office to reach a consensus. Any underlying administrative issues will then be decided by DAP, Silverman said. The field office is responsible for the logistics of the particular case.

Silverman stressed that involvement of field offices remains an important piece of the compliance picture. “We don’t want a model where CDRH defines quality, dictates it to the [Office of Regulatory Affairs], and then they pass it down to the field offices,” he said. “In my experience, that doesn’t work.”

The new international division integrates import and export responsibilities with a focus on export-related compliance events that previously went unmonitored. DICO also houses the Medical Devices Single Audit Program and serves as the main point of interaction between CDRH and foreign regulatory authorities.

Another new division, DLPC, keeps an eye on 510(k)-cleared products to see if manufacturers are making any claims not covered in the 510(k). The division is part of an agencywide effort to monitor marketing via social media — “concerns we didn’t sufficiently address” in the past, Silverman said.

Finally, DMQ is at the center of an office-wide effort to improve the quality of medical devices and has helped OC further its role in the FDA-level Case for Quality Initiative, Silverman noted. The division has also led to closer work with the Office of Regulatory Affairs Case for Quality goals, he said.

Some aspects of OC’s work, such as the agency’s cooperation with the Federal Trade Commission and decisions on warning letters, haven’t changed with the reorganization, Silverman said. He noted that the restructuring has actually led to “some gains in efficiency” in issuing warning letters.

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