CDRH's Office of Compliance Reorganization

CDRH’s Office of Compliance Reorganization - Webinar CD/Transcript

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CDRH’s Office of Compliance Reorganization: A “One-On-One” with Office Director Steve Silverman

CDRH has recently overhauled its Office of Compliance – what exactly has changed and what hasn’t?  What does your team need to know going forward in order to deal with the Office of Compliance?  What does the OC expect from you?

These are just a few of the important questions you need to ask. There is only so much you can learn from the diagrams and organizational charts provided by the FDA. 

Order this exclusive question-and-answer webinar CD and transcript set with FDA veteran Steve Niedelman, lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, as he speaks with Steve Silverman, Director of CDRH’s Office of Compliance, to help you understand all the changes.

They discuss:

  • How the reorganization will impact any pending business with the OC
  • Whether or not you’ll need to set up new contacts with regard to compliance issues
  • What you can expect from each new director and staff

With the recent reorganization of the Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH), the office will sharpen its focus on international inspections and audits on labeling.

The office has also replaced the office’s former four–division structure with five divisions, with each division containing a number of sub-branches. The divisions are as follows:

  • Analysis and Program Operations (DAPO), which will handle establishment registration and listing, facility inspections, and supports recalls;
  • Bioresearch Monitoring (DBM), which will provide oversight of clinical trials and coordinate inspections of regulated parties;
  • International Compliance Operations (DICO), which will focus on issues relating to foreign device manufacturers, imports and exports, and also oversee an international audit program;
  • 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
  • Premarket and Labeling Compliance (DPLC), which will enforce requirements regarding premarket clearance and approval, labeling and advertising.

Here’s who will benefit from your organization:

  • Regulatory Affairs
  • Legal Counsel
  • Compliance Officers
  • Marketing Officers
  • Management Personnel

Meet Your Instructors

Steve Silverman is the Director of CDRH’s Office of Compliance. In this role, he oversees a staff of more than 170 scientific and regulatory personnel who assure compliance with the medical-device related provisions of the federal Food, Drug, and Cosmetic Act and its implementing regulations. Mr. Silverman also represents CDRH on an agency-wide globalization initiative, and leads a Center-wide compliance strategic planning effort.

Steven Niedelman serves as lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, specializing in regulatory, enforcement and policy matters involving industries regulated by the U.S. Food and Drug Administration. He provides strategic advice, insight and guidance to the medical device, pharmaceutical, biologics and food industries to ensure compliance with the requirements of the federal Food, Drug and Cosmetic Act. Mr. Niedelman retired from the Food and Drug Administration in 2006 after a 34-year distinguished career, where he served as the Deputy Associate Commissioner for Regulatory Affairs and as Chief Operating Officer of the Office of Regulatory Affairs.