Michael Causey, Editor & Publisher, eDataIntegrityReport.com
Well, the eMDR comment period has come and gone – and I’ve got to say I’m a little surprised at the relatively low number of comments. But let’s look on the bright side: What we didn’t get in quantity we might have gotten in quality. This is generally as well-articulated and intelligent a group of comments I’ve read in years.
The overall tone of the letters can be summed up like this: Some want more time to implement the rule, while most generally support the eMDR initiative and call for some changes, mostly of a relatively minor, if probably justified, nature.
A few days before the comment period ended, I spoke with Axis Technology President Mike Logan about why there were so few comments. A handful came in after we spoke on Nov. 11, but he and I are still both a bit surprised there weren’t ultimately more comments.
His view: “Right now I believe people are taking a ‘wait and see’ approach until more firm details are unveiled. As nice of an idea the eMDR is, there are a lot of risks involved and questions that need to be answered, such as how this impacts standards compliance and potential liabilities.” Axis is a provider of IT consulting and data security offerings for healthcare industry organizations.
Some of the comments seek the kind of clarification Logan believes some in industry need before they are fully confident in using eMDR.
From a medical device standpoint, AdvaMed’s comment is one of the most important since it speaks for so many others (its member companies produce nearly 90 percent of the health care technology purchased each year in the U.S.). It’s also worth noting that the trade association can “get away” with saying things to the FDA that an individual company might not want to risk.
At the outset, AdvaMed says it supports the initiative. But, and there’s always a but in cases like this, they want to see the time stamp issue clarified, a concern echoed by Abbott. AdvaMed also wants the agency to adopt the date and time in the first acknowledgement sent to the submitter by the FDA that the report was received. It also wants the agency to develop a grace period for companies when they have a system outage, among a few other requests.
AdvaMed also wants the final rule to take effect at least two years after publication of the final rule.
On balance, most of the changes requested by the comment letters strike me as reasonable. Industry won’t get everything it asks for here, but I suspect the FDA will work pretty hard to accommodate the most reasonable requests.
Remember, the agency is still smarting from how it mishandled 21 CFR Part 11 in 1997. Back then, it made the rule way too literal and hands-on. Its stated goal to was to advance the use of technology; instead the FDA set it back for several years.
In many ways, I think the agency is to be commended for learning from its mistakes with Part 11 and applying them to its rollout of eMDR. The eMDR guidance is not perfect for everyone, but it’s pretty good for almost all, and that kind of effective compromise strikes me as democracy at its best. Here’s hoping the FDA takes some of the best comments to heart and improves a guidance that’s pretty close to the mark.
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[...] for a slew of reasons; and few, if any, have to do with the content in the rule itself. Indeed, the agency has been surprised how little comment the eMDR rule proposal received. It’s no longer very controversial, and industry realizes that it [...]