Is My Product a MDDS?
I’ve been getting a lot of questions about this. Here’s the latest:
I am hoping you can answer this question for me. Would [redacted company name] a data storage company come under the MDDS final Ruling? Are hw/sw services all types of companies including medical.
Unfortunately, where the FDA is concerned, very little is black or white. Short to-the-point questions usually don’t result in meaningful answers.
One unambiguous issue we can get out of the way is that the FDA regulates products through their regulation of manufacturers. All regulatory questions revolve around the product, but it is the manufacturer of the product that has to jump through the regulatory hoops. A manufacturer may chose to have one set of policies and procedures that conform to the FDA regulations for their medical device, and another for unregulated products.
Navigating Regulatory Uncertainty for Smartphones
Uncertainty abounds regarding the potential regulation of smartphone apps by FDA and other international regulatory bodies. For this discussion we’ll divide uncertainty into two categories, uncertainty due to a lack of knowledge about the potential regulations on the part of manufacturers and uncertainty about just what various regulatory agencies are doing – or going to do – about new and innovative products that meet the definition of a medical device.
What is a Medical Device?
Let’s start with the first category; there is an astounding amount of misinformation and just plain wrong-headedness on the part of many vendors (and providers) who are outside the ranks of traditional medical device manufacturers. The first issue we need to address is the question, “What is a medical device?” Here’s the legal definition of a medical device, courtesy of FDA:
Charting Your Regulatory Course
Do you think your product could be a medical device, and regulated by FDA?
There are all kinds of regulatory strategies. Any new product development project for a regulated product should have a regulatory strategy that optimizes requirements, specifications, risk and verification testing, especially as it relates to the off the shelf components of a medical device. I would call this a product-specific regulatory strategy.
At the other end of the spectrum, a company should have a regulatory strategy that charts the regulatory course of the company in addition to its relevant products. Companies already regulated by FDA should have one of these as part of their management responsibilities – and it should be kept up to date as products, the company, and the regulatory environment change over time. Let’s call this a corporate regulatory strategy.
You especially need a corporate regulatory strategy if your company’s products, or the products of companies you see as direct competition, are in that gray zone that could maybe be interpreted as a regulated medical device.
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 Technologies, Nuvon 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.
Meaningful Use Stage II
My February, 2010 discussion of Meaningful Use (MU) (found here) addressed the then proposed 25 elements by which an EMR/EHR (hereafter EMR) would be judged in order to determine if it met the funding standard for MU under the U.S. federal incentive program regulations. Note that in this regard an EMR must be capable of MU, and then MU must be actually achieved by the end user. Capability is established by vendor certification.
As is perhaps common in the sequence of proposed and revised federal regulations, that the scope of the 25 elements received a degree of adverse response that centered on the assertion that they were overly demanding, i.e. we want the money, we just don’t want to work that hard to get it. As a result the 25 required elements were reduced to two sets of requirements in what is now called Stage 1. The first set is 15 required elements while the second is a “menu” of 10 additional elements of which 5 must be chosen.
Impact of Potential FDA Regulation of EMRs
Santa Rosa Consulting has a great series of webinars on medical device connectivity and related issues, and I’ve been tapped for the October webinar. My topic revolves around the likely regulation of EMRs by the FDA and the potential impacts such a change might have on providers and manufacturers.
The following is my first take on the topic, and serves as a description of webinar. Any suggestions, points of view and links to relevant content on the Web (news stories, blog posts, regulations, etc.) is welcome.
Register for this webinar here, to be held on October 27, 2010 from noon to 1pm EST.
The Case for Regulating EMRs
From a quarter century point of view, it seems inevitable that the HIT industry will be regulated by the FDA. Look past all the hand waving and hyperventilating caused by this suggestion, and one sees that the HIT industry is already regulated by the FDA. For examples, look no further than blood bank software and PACS. The Center for Biologics Evaluation and Research (CBER) started regulating blood bank software via the premarket submission process in 1996. From their inception, the FDA considered PACS as accessories to diagnostic imaging modalities, and thus regulated. (Many PACS components have since been reclassified in recognition of their independence from imaging modalities.)
These examples aside, the HIT industry has pretty much avoided FDA scrutiny by claiming they’re just automating administrative tasks and paperwork (i.e., workflow around the paper chart).With the advent of decision support systems tied to CPOE and other applications, “administrative” HIT systems have come to be increasingly recognized as a source of patient safety risk. See Margalit Gur-Arie’s post at the KevinMD blog.Perhaps the story that’s created the most buzz about the danger of EMRs is this Huffington Post piece from April, 2010.
On February 25, 2010, at a HHS panel meeting, Jeff Shuren reported:
The Food & Drug Administration has received 260 reports of health IT-related malfunctions with the potential for patient harm in the past two years, including 44 reported injuries and six reported deaths, said Dr. Jeffrey Shuren, director of FDA’s Center of Devices and Radiological Health.
