FDA Seeks Public/Private Partners For Device Epidemiology Network

Article preview from "The Gray Sheet"-  May 10, 2010

FDA is forming a public/private epidemiology network focused on better understanding of medical device performance over a product's lifespan.

Article preview from "The Gray Sheet"-  May 10, 2010

FDA is forming a public/private epidemiology network focused on better understanding of medical device performance over a product's lifespan.

The initiative, known as the Medical Device Epidemiology Network, or MDEpiNet, is being run out of the Office of Surveillance and Biometrics' Division of Epidemiology within FDA's device center.

A final model for the program will be announced by the end of the summer. Initial plans call for a partnership between FDA and academia, but industry and other groups may also be involved. A formal launch is envisioned by the end of the year.

"It is geared toward improving the total product lifecycle," Danica Marinac-Dabic, director of the center's epidemiology division, told "The Gray Sheet."

CDRH unveiled the initiative at an April 30 workshop at FDA's White Oak campus.

Organizers hope MDEpiNet will enable FDA to synthesize the best evidence on device performance from various sources and develop better, innovative methods for studying devices in the pre-and post-market settings, Marinac-Dabic explained.

The epidemiology network will also enable the participants to develop innovative ways to analyze data, she said.

Epidemiology, the branch of medicine focused on studying diseases across populations, "is the basic science of public health," Marinac-Dabic explained.

"Improving how the epidemiological study of basic products is being conducted will have a huge implication on the design and [implementation] of clinical studies."

MDEpiNet will focus initially on developing research projects to address gaps in orthopedic and cardiovascular device data. FDA is already pursuing three pilot projects in these areas, which will expand once the network fully launches.

The idea is to create an infrastructure that would provide CDRH reviewers with the best available data from studies and registries inside and outside the U.S., from administrative data and other "rich sources of information," she said.

-Mark Hollmer


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