FDA Guidance Balancing Premarket and Postmarket Data Collection for Devices

In releasing guidance entitled, "Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval - Draft Guidance for Industry and Food and Drug Administration Staff," FDA attempts to clarify current policy on balancing premarket and postmarket data collection during the Agency's review of premarket approval applications (PMAs).
Comments and suggestions regarding the draft document are due by July 22, 2014. Submit electronic comments to http://www.regulations.gov/.  Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions about this document concerning devices regulated by CDRH, contact the Office of the Center Director at 301-796-5900. For questions about this document concerning devices regulated by CBER, contact the Office of Communication, Outreach and Development (OCOD) by calling 1-800-835-4709 or 301-827-1800.
I. Introduction
The draft guidance clarifies the Food and Drug Administration's (FDA or the Agency) current policy on balancing premarket and postmarket data collection during FDA review of premarket approval (PMA) applications. More specifically, the guidance outlines how FDA considers the role of postmarket information in determining the extent of data that should be collected ...

Source: Policy and Medicine - July 21, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs