April 18, 2008
Update from the FDA provided by www.eDataIntegrityReport.com
eMDR Regulation Slow, But Guidance "Nearly Complete"
A recent article and eblast in eDataIntegrityReport quoted FDA electronic Medical Device Reporting (eMDR) point man Stephen Sykes as saying that the eMDR "guidance" was moving "slowly through the government bureaucracy" and won't be coming out soon. However, Sykes has corrected us to note that it is actually the regulation that is moving slowly thru the review process. "The guidance, however, is nearly complete, and the technical documentation for the system is available now" Sykes told EDIR this week.
Sykes is Deputy Director, Office of Surveillance and Biometrics, Center for Devices and Radiological Health at the FDA.
April 2008
eMDR Webinar to be held May 8, 2008 - 10 am PT | 1pm ET
Inefficient medical device reporting presents a clear and present danger: It can damage your company’s reputation and even threaten your ability to operate. After sending some mixed signals in the second half of 2007, FDA eMDR experts have said they’ll mandate eMDR within two years. The only debate now is how quickly it will happen, and what kind of extension smaller device companies may get.
For more information about this free webinar, click here.
March 2008
Update from the FDA provided by www.eDataIntegrityReport.com
eMDR: Stalled, but not forgotten?
The FDA’s point-person on the electronic Medical Device Reporting (eMDR) initiative just told us that the guidance won’t be coming out this month as hoped – and it’s anybody’s guess when it will finally emerge.
“It’s going slowly through the government bureaucracy,” said Steve Sykes, Deputy Director, Office of Surveillance and Biometrics with the Center for Devices and Radiological Health (CDRH), in an exclusive interview with EDIR March 26. He said that the delay should not be interpreted as the FDA losing interest in the project. “I’m disappointed” by the pace, he added.
However, Sykes said he hoped medical device companies would soon embrace the eMDR initiative regardless of a guidance being issued for comment. “We’re ready to receive,” he said. On the downside, there have not been any additional device companies or other industry players who have asked the FDA to participate since the initial companies came forward last year, he said.
The reason? “I think part of it is that medical device companies are using this as an opportunity to revamp their entire Adverse Events systems, rather than just hook in with the FDA’s eMDR program now.”
“It’s at least 18 months away” from being made mandatory, Sykes told us at the end of 2007. He still hopeful on a rough timetable that goes something like this: The agency will issue draft guidance in the first half of 2008, take comments for 90 days, and then issue a final rule that will mandate eMDR within a year of the final rule coming out.
February 2008
AssurX eMDR preview event a tremendous success! Customers and prospects comment on the solution:
"I really love the look/feel/ease of use for the new eMDR solution."
"Once again, the AssurX team and their product establishes and maintains superiority over the rest."
"I really do think the eMDR solution AssurX created is super slick!"
Want to see for yourself? Request to view the recorded demo.
January 2008
AssurX releases a new, informative eBook on eMDR
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Leveraging the Benefits of eMDR: A Guide to Taking Advantage of eMDR to Improve your Operations – This complimentary eBook goes into detail about how eMDR works, what the FDA says about eMDR, and the benefits of adopting this technology through developing an effective strategy. Request your eMDR eBook today! |
December 2007
AssurX eMDR (Electronic Medical Device Reporting) Update:
Due to the overwhelming amount of questions we get asked about our upcoming eMDR (Electronic Medical Device Reporting) solution, we’ve put together this Q&A to let you know what we’ve been up to:
Question: Is AssurX going to have an eMDR (Electronic Medical Device Reporting) solution?
Answer: Yes
Question: When will it be available?
Answer: AssurX doesn’t pre-announce product launch dates. But what we can say is we’ll be ready with eMDR when the FDA is ready to receive them through their AS2 production system. Currently they are still in testing stage, and haven’t gone live.
Question: Are you currently testing the eMDR system with the FDA?
Answer: Yes. In fact, we’ve also helped them solve a few irregularities with XML translation files, which have in turn helped all the vendors participating in this program.
Question: Has your testing been successful?
Answer: Yes, as we’ve hit all the milestones including receiving all acknowledgements, etc., from the FDA.
Question: Has anyone seen your system?
Answer: Yes, we did a live demonstration at our AssurX Summit user conference to all of our customers in attendance back in September 2007.
Question: Do you have customers who are testing the system as well?
Answer: Yes, we have several who are on board for testing.
Question: Other vendors are touting they’ve been working closely with the FDA. Has AssurX been doing the same?
Answer: Yes, we’ve been working with the FDA all along. We’ve also helped solve several irregularities we’ve found along the way. See above.
Questions: Do you think the FDA will make eMDR mandatory?
Answer: Maybe. We’ll have to wait and see what happens after the comment period scheduled for Q1 next year.
If you have any further questions, please feel free to contact Tamar M. June, VP of Marketing at 408-778-1376, ext. 705.
If you would like to be kept up to date about eMDR at AssurX, please send us an email at emdr@assurx.com.
