Daily Rules, Proposed Rules, and Notices of the Federal Government
If you need special accommodations due to a disability, please contact Joyce Raines, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4319, Silver Spring, MD 20993, 301-796-5709, email:
To register for the public workshop, please visit FDA's Medical Devices News & Events—Workshops & Conferences calendar at
Regardless of attendance at the meeting, interested persons may submit either written comments regarding this document to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 or electronic comments to
MDEpiNet is a collaborative program through which the Center for Devices and Radiological Health and external partners share information and resources to enhance our understanding of how well medical devices work (
Accomplishing MDEpiNet's mission will require leveraging of resources, skills, and expertise from a variety of partners, and we encourage participation from all stakeholders, including other Government Agencies, academia, health care industry organizations, and patient and consumer groups. The purpose of the public workshop is to facilitate discussion among these key stakeholders in the scientific community on issues related to medical device epidemiology methodology and infrastructure as it relates to evidence generation and synthesis across the Total Product Life Cycle. This public workshop is open to all interested parties. The target audience is professionals from other Government Agencies, academia, professional societies, health care industry organizations, patient and consumer groups, and other professionals in the scientific community interested in advancing the infrastructure and methodology for epidemiologic understanding of medical devices and procedures.
We intend to discuss a large number of issues at the public workshop, including but not limited to the following: (1) Status and updates from MDEpiNet Methodology and Infrastructure Centers; (2) proposed partnership structure and governance; (3) MDEpiNet as a framework for medical device postmarket surveillance and its relation to the Sentinel provision in the FDA Safety and Innovation Act (calling for the expansion of the postmarket risk identification and analysis system to include devices); and (4) action plan and prioritization of MDEpiNet partnership efforts for the upcoming year.