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February 2012

eMDR Conversion and Implementation - Part I

by Eugene Reilly
FDA's Center for Devices and Radiological Health

The electronic Medical Device Reporting (eMDR) program allows for the electronic submission of mandatory medical device reports (MDRs), which are regulated under federal law (21 CFR 803). The eMDR program changes how reports are submitted—it does not change what is considered reportable or what information those reports should contain.

The electronic MDRs are sent in a standard format, specifically the Health Level Seven (HL7) v3 Individual Case Safety Report (ICSR) release 1 data model. Each type of MDR submitted (intial/30-day, 5-day, and supplements to already submitted reports) are sent using a single ICSR report.

There are two options for submitting MDRs electronically, and both options are available to all reporters.

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Cindy Fazzi

FDA Says Part 11 Guidance Remains Status Quo

by Cindy Fazzi
Marketing Communications Specialist, MasterControl, Inc.

Time and again, rumors surface about the possible update of the 2003 guidance on the scope and application of 21 CFR Part 11. The never-ending speculation attests to the enduring interest in Part 11, not to mention the continued scrutiny of the regulation.

Asked to comment on the status of the 2003 guidance, Erica Jefferson, an FDA press officer, told GxP Lifeline: "There are currently no plans to update the guidance. We are still performing inspections per the 2003 guidance."

Jefferson, FDA Office of Public Affairs' team leader for medical products and tobacco, said the agency has been conducting "focused" inspections since 2010. "For the past year and a half, the FDA has been performing some focused inspections related to Part 11 controls in an effort to determine industry compliance and understanding," she said.

Part 11 is here to stay, and the 2003 guidance remains in place. So, what does this mean for your company? Quite simply, it means understanding Part 11 is critical, now more than ever.

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MD&M East
May 21-24, 2012, Philadelphia, PA

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Did you know that the FDA has created a new guidance that helps medical device manufacturers and study sponsors determine how their study data should be formatted for electronic submission?
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