Article preview from "The Gray Sheet"- March 12, 2012
FDA’s device center seems agreeable to the concept of “pre-522” study meetings, raised by industry last week as a means to make the post-market study order process more efficient.
Article preview from "The Gray Sheet"- March 12, 2012
The device center will consider interacting with device makers before formally issuing Section 522 post-market study orders to speed up the process and let companies prepare for the mandated studies earlier, CDRH officials said last week.
The idea of “pre-522” meetings was discussed at a March 7 FDA workshop in Silver Spring, Md., on the design and methodology of Section 522 post-market surveillance studies.
Section 522 of the Food, Drug and Cosmetic Act allows FDA to mandate post-market studies for class II and III products that are life-sustaining or life-supporting, are implanted in the body for more than a year, have significant use in pediatric populations, or whose failure would likely lead to serious health consequences.
At the workshop, FDA officials emphasized that firms can and should utilize device registries and other existing data sources to lessen the burden of carrying out Sec. 522 studies.
While industry representatives expressed interest in using such resources, they stressed that meeting the tight timeframes for complying with 522 study requirements is still a major challenge.
Continued...
To read this article in its entirety, Purchase now as a PDF and receive it immediately via email. Or get it FREE when you subscribe to Medtech Insight Newsletter.
About Medtech Insight
Medtech Insight newsletter provides insights into the technology and market developments (devices, instrumentation, biomaterials, gene therapy, tissue engineering, etc.) impacting a wide range of surgical and non-surgical clinical practices.
Plus:
To find out about more about more about Elsevier Business Intelligence's medical device publications and databases, multi-user access and/or advertising with Medical Devices Today, please contact Kristy Kennedy at (480) 985-9512
Comments