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