Top 7 Keys to eMDR Success:The Deadline is Near, Are You Ready?
The deadline looms.
Devicemakers must take steps now to secure a production account for submitting electronic Medical Device Reports (eMDRs), ahead of an Aug. 14, 2015 deadline for compliance. The FDA set the deadline in a final rule issued Feb. 14, 2014.
In providing guidance on the rule, the FDA emphasizes that eMDRs include the same information as paper MDRs. To begin submitting eMDRs, a manufacturer needs to:
Request a Web Trader account from the FDA’s Electronic Submissions Gateway;
Submit a Letter of Non-Repudiation to the agency;
Obtain a personal digital certificate; and
Submit a mock report as test data.
Devicemakers have two choices for preparing eMDRs. One option is the FDA’s free eSubmitter software, by which manufacturers can manually enter case data for transmission to the agency. The other option is Health Level Seven (HL7) Individual Case Safety Reporting, which allows for batch report preparations.
But unlike eSubmitter, HL7 does not permit users to print the report. Because of this, “entities who choose this option are encouraged to develop systems that can save or print the resultant report and that can encode attachments into their eMDRs,” the guidance says.
Which way should you go? What are the plusses and minuses of each option?
In 90 Minutes You Will Learn:
How to understand the three very different ways to transform your data into an XML file. How to select the one that’s right for your organization. (Hint: Your first guess is probably wrong.)
How to become a “transaction partner” with the FDA. Get it wrong and you’re off on the wrong foot from the very beginning (Hint: If you don’t know what a “transaction partner” is, you’d better attend this webinar.)
Ways to leverage the ACK (Acknowledgements) process to demonstrate compliance with the FDA, which one of three paths should you choose, and how to handle a “negative” acknowledgement from the FDA. (Hint: Better be ready to monitor and understand ACK problems early.)
Why it is critical to test now before the FDA tests you. Learn which of the six testing methods is best for your organization. (Hint: You need to develop a plan of action TODAY.)
Lift the best ideas from proven best practices of successful companies. Their pain can be your gain. (Hint: Do you know why you should avoid 3-year certificates?)
How to steer clear of deadline and other time-related problems. (Hint: Have you built-in open and update document capabilities?)
The end is just the beginning. Remember, what works for you in August may not work next January. (Hint: Are you prepared to leverage adverse event reporting analytics to track trends and initiate corrective actions?)
Medical device manufacturing and executives
Auditing and compliance officers
QA/QC managers and directors
Process development staff
Auditing and compliance officers
Regulatory affairs professionals
Personnel new to the industry
Deborah Kacera is Regulatory and Industry Strategist at Pilgrim Quality Solutions, a leading global provider of enterprise quality management software and services. As key strategist, Deb is Pilgrim’s liaison with global regulatory bodies, including the FDA and EMEA-regulated bodies, within the Life Sciences industry, including Medical Devices, Pharmaceuticals, Biologics and Blood & Tissue. Her insights into regulatory requirements continuously drive her efforts to build on Pilgrim’s current quality and compliance management solutions to support their relevance among Life Science markets.