Final MDDS Rule Signals FDA Shift to Enforcement

Final MDDS Rule Signals FDA Shift to Enforcement

On February 14, 2011 the FDA published notice (PDF version [link fixed] and press release) of the long awaited final rule for medical device data systems (MDDS). The real news behind the final MDDS rule is not the less-burdensome path to market trumpeted by many news stories, but the FDA’s stated intent to exercise “enforcement discretion” with regard to those who create MDDS. For the MDDS vendors who are already regulated (Capsule Tech, Cardiopulmonary Corp, Dawning TechnologiesNuvon and others) this final rule is an easing of the regulatory burden. For those that aren’t (e.g., Bridge-Tech Medical, CareTrends, iSirona and others – I currently track 16 companies in the MDDS category) this final rule signals that FDA enforcement actions will be forthcoming for manufacturers that don’t meet FDA’s implementation deadlines (more on that later).

The final rule reclassifies MDDS from a Class III postamendment device to Class I (general controls). Device reclassification has been used before to signal industry that FDA is transitioning from “regulatory discretion,” where the FDA takes a wait-and-see approach to nascent markets, to pursuing “enforcement discretion” to actively regulate new market segments.

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Canada Posts “Medical Device Data System” Rule

On August 31, 2009 Health Canada, Canada’s medical device regulatory authority, posted classification information for Patient Management Software (pdf). This action is similar to the FDA’s proposed rule for the regulation of Medical Device Data Systems (MDDS), nearing finalization. The Canadian announcement begins with a reminder of its definition of “medical device” which is similar to although not identical to the U.S definition. This definition includes Patient Management Software as a medical device. In addition, Canada defines an “active” device as one that requires an energy source, and “active diagnostic device” as one that is intended to supply information for the purpose of detecting, monitoring or treating a physiological condition, state of health, illness or congenital deformity. Based on these definitions patient management software is declared to be first a medical device, and then an active medical device.

The next question is the appropriate classification of this type of active medical device under the Canadian classification system. The Canadian system has four device classifications which is similar to the European system. The U.S., of course, has three classifications.

Patient Management Software that is used only for archiving or viewing information or images, and is not involved in the primary acquisition, manipulation or transfer of data is deemed to be a Class I device.  This definition is somewhat more restrictive than that for a U.S Class I MDDS. Any Patient Management Software that goes beyond these restrictions is a Canadian Class II device. Furthermore such software is categorized as an active diagnostic device. This includes software involved in data manipulation, graphing, flagging of results or performing calculations. Workstations that interface with such software are then also in Class II. The inclusion of the work station appears to directly address the illusive question of when does a computer become a medical device. As a result of these new distinctions some software that was previously Class I (in Canada) will now be Class II. The manufacturers of such systems sold in Canada have been granted a one year transition period to meet those aspects of Class II regulation that are different from or in addition to those for Class I. This defined transition period is a more explicit statement than the FDA has provided in the draft MDDS rule.

The distinctions between system functions made in Canada are somewhat different from those initially defined by the FDA for MDDS. None-the-less they reflect essentially the same issues and concerns which are that (1) any software that receives and manipulates patient data is a medical device, and (2) that the appropriate classification depends in part on exactly what the software does with the data. Only minimal data handling activities are in the least stringent regulatory classification, while classification and therefore regulatory scrutiny will increase along with the sophistication of what the software does.

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Final MDDS Rule Expected Soon

In an off the record conversation couple months ago I was assured by an FDA contact that they were indeed working on a final version of the MDDS rule. Then this past Friday, David Bowerman with VisICU said that he’d heard that the FDA was going to publish the final draft in a few months.

After some poking around, I came across this page on SoftwareCPR (by the time you visit the page, the 4/7/09 entry may have scrolled off the page). At the top was this intriguing bit:

At public conferences representatives of the FDA have indicated that the draft Medical Device Data System Classification rule was returned from FDA legal review for clarification of how public comments were addressed. This will delay release of the final rule perhaps 3 – 6 months but it is hard to estimate.

On the same page of news, I saw that John Murray, with the CDRH Software Compliance office, gave a presentation at the recent AAMI Standards Conference on what software is a medical device, how such software is classified, and whether pre market submissions are required or the quality system regulation applies. (An interesting presentation (pdf) that you can download here.) Thinking this may be one of the “public conferences” where “the FDA have indicated” the status and not too distant release of a final rule, I give John a call. Here’s what he said:

  1. FDA legal had indeed come back with a request to more fully address the public comments in the final rule.
  2. He described the majority of comments as focused on wanting a better understanding the proposed rule’s definitions.
  3. Consequently, the preamble will be expanded to include better definitions.
  4. That the basic rule itself will be unchanged.
  5. And yes, the final rule is close to being published.

When asked about the 3 to 6 month time frame to finish tweaking and publish the final rule, John declined to site a specific time frame.

Compliance Requirements

The proposed rule includes specific time frames for manufacturers to come into compliance. The draft MDDS rule states that vendors have 60 days after the final rule is published to register with the FDA as a medical device vendor and provide a list of their products. Manufacturers who fall under premarket notification (510k) have 90 days to submit, and 180 days to obtain final clearance. This is not a whole lot of time.

Since the draft rule was published, vendor reactions have ranged from “wait and see,” to accepting the MDDS rule as a foregone conclusion and moving towards compliance. This puts some vendors facing FDA regulatory scrutiny in a bit of a pickle.

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Facing FDA Regulations for the First Time

A growing number of organizations — large and small, within health care and outside of it — are facing regulation by the FDA. Those potentially affected fall into 3 camps. All of the examples I’m going to talk about deal with multi vendor systems (or systems using lots of off the shelf components) that become the regulated medical device.

Just what is a medical device? The legal definition of a medical device is,

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

  • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, [i.e., a drug]
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it’s primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

According to the New Oxford American Dictionary, a contrivance is “a thing that is created skillfully and inventively to serve a particular purpose.” So a medical device can be made out of anything, as long as it falls under at least one of the three bullets above.

Who Is Impacted?

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FDA MDDS Webinar

As the FDA grinds through the comments submitted in response to their proposed rule for medical device data systems (MDDS), the market awaits the final rule. Regardless of changes between the proposed and final rules, vendors who may be regulated under the new rule will have limited time to prepare.

Awhile back, I was contacted by ComplianceOnline to author a webinar on the FDA’s proposed MDDS rule. After some discussion, we agreed on the following pithy title: The FDA’s proposed Medical Device Data System (MDDS) rule and its implications for currently regulated and unregulated vendors and providers. The key objectives for the webinar are to provide clairification on the proposed rule and explore the consequences for those involved with MDDS – vendors and hospitals.

You can read a description and register for the webinar here. Attendees are encourage to submit questions – which I will answer during and after the webinar.

Alas, the webinar is not free. But compared to what it would cost in my time to lay out the proposed MDDS rule and its implications in detail, the price is a bargin.

If you have any questions about the webinar or MDDS, feel free to contact me (scroll down to the bottom of the page). You can also leave questions on the web page promoting the webinar.

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