Wanted: Evenhanded FDA Enforcement

FDA needs to be consistent in its enforcement of regulations. The issue of preselling mobile medical devices provides a case in point.

By Bradley Merrill Thompson


Just about everyone in the medical device industry knows that companies are not allowed to begin selling their medical devices until they have obtained the necessary FDA clearance. But while that’s been the case since Congress enacted the 1976 Medical Device Amendments, recent FDA inaction in the context of mobile medical apps is causing confusion. If the rule has somehow changed, FDA should let everyone know that. But if the rule has not changed, FDA needs to apply the rule consistently.


I first raised the issue of consistent enforcement about a year ago, when I wrote a post on MD+DI asking FDA to start applying its enforcement actions more evenly with companies that were plainly selling medical devices without the required FDA clearance. At the time, I was focused on mobile medical apps that clearly met the definition of a medical device, and I illustrated my point with the uChek App, a mobile app that caused a cell phone to function as a urinalysis instrument. Back then, the company making the uChek app, Biosense, was making medical claims about testing urine for occult blood and glucose, among other things, while disclaiming that its product was a medical device. A couple of months after I wrote that post, FDA took action, sending the company an enforcement letter.

New Case Study

New year, same enforcement consistency issue, new context. Say hello to Wello, a health tracker that doubles as a phone cover. According to the manufacturer, Azoi, “You simply hold it and hidden sensors begin testing your vitals. This information is then quickly passed to an app that's synced to your phone. Not only do you get an instant idea about your health, over time you are able to see patterns that help you manage your life better.”

The website explains the specific vital signs the devices intended to measure, including blood pressure, ECG, heart rate, blood oxygen, and temperature. Indeed, when you watch the video available on the Azoi’s site, the company explicitly says that all of these measurements are taken to “medical grade.”

But wait, there’s more.

According to the Web site, “while Wello tests your vitals through a series of heart function tests, it also comes with a nifty add-on device” that tests your lungs to read “how much air you can inhale and exhale, which may point towards possible obstructions or underlying conditions.” In a video, Azoi explains the attachment is a spirometer that tells you your lung capacity and airflow. People with asthma and other such diseases use spirometer’s to regularly check their lung function.

But here’s the important point. Even though this product clearly requires FDA clearance in the United States, Azoi decided to go ahead and take orders now, with customers paying by credit card. So you can preorder the kit all for the low, low price of $199.

Indeed, in the frequently asked questions section of the company’s Web site, Azoi explains:

Is Wello FDA approved?

No. Wello is not yet an FDA approved device. If you are ordering in the United States, we will ship the product to you once we have received approval from the FDA. …In USA it will ship in Fall 2014…."

I agree with Azoi that its kit will be FDA regulated. Specifically, for example, a peak-flow meter for spirometry falls under Class II, according to 21 CFR 868.1860, and electrocardiograph electrodes that touch the patient’s skin (as in the Wello phone case) fall under Class II according to 21 CFR 870.2360.

But here’s the problem. It is illegal to presell medical devices that require FDA clearance in the United States. And Azoi seems to well understand that its product does, in fact, require FDA clearance in the United States.

U.S. Law and Policy on Preselling

Okay, here’s the boring part, but I will compress it down. Section 301 of the Federal Food, Drug, and Cosmetic Act prohibits the introduction into interstate commerce of a device that is adulterated. A medical device is considered adulterated if it requires FDA clearance but has none.

So right now you’re probably asking, “What does it mean to introduce a product into interstate commerce?” In fact, some of you are probably thinking the phrase means shipment. Admit it, that’s what you first thought.

Well FDA answered that question in a formal opinion a long time ago, back in 1978. In a Compliance Policy Guide that defines what activities may constitute forbidden commercial distribution before a device is cleared for marketing, FDA explains:

This opinion affects device firms' promotional activities during the pendency of 510(k)'s (premarket notification submission). Although a firm may advertise or display a device that is the subject of a pending 510(k) -- in the hope that FDA will conclude that the device is substantially equivalent to a pre-amendments device -- a firm may not take orders, or be prepared to take orders, that might result in contracts of sale for the device unless limited to research or investigational use."

In this case, investigational use means a clinical trial used to develop needed data, conducted in compliance with the investigational device exemption regulations.

The law is gray in many areas, but not here. Where Azoi has said that it is pursuing FDA clearance and is not conducting a clinical trial, there simply is no doubt that the company cannot legally take orders. Yet that is exactly what it is doing.

You might wonder what the policy is behind this law. Why, for example, the law would simply not say that companies are forbidden from actually shipping product until they receive FDA clearance? Neither Congress nor FDA has provided much explanation as to why the line is drawn where it is, but we can suppose there are several advantages to the government for drawing the line at preselling. I’ll offer a few possibilities:

  1. The claims that a manufacturer can make about its product are specifically addressed during the course of the FDA review, and frequently the subject of negotiation and adjustment. So how can a manufacturer take money for a product when the permissible claims have not yet been resolved? Likewise, sometimes even the basic design of the device must change to meet FDA standards.
  2. Entering into a contract for the preselling of a medical device creates a powerful incentive for a company to actually ship the device to please its customers. The government may well be worried that this incentive may be too much for companies to resist when FDA clearance is either slow or not forthcoming.
  3. Even if it does not lead to releasing the product before clearance, FDA may have concerns that companies will cut corners in order to comply with contractual deadlines.
  4. From a more constitutional law standpoint, entering into contracts does impact interstate commerce in the sense that the buyer makes a choice among competing products, meaning the buyer elects not to purchase a product that is lawfully on the market.

Personally, I think all of those policies are debatable. And indeed, maybe this issue should be revisited for all medical device manufacturers. But in the meantime, the agency’s position as expressed since the 1970s is clear.

Evenhanded FDA Enforcement

A year ago I outlined the various arguments for why FDA can’t adopt a double standard, telling device companies to comply with one set of rules while turning a blind eye to the activities of others. For everyone who makes a medical device, we need one set of rules that are applied consistently.

Further, it creates enormous confusion when FDA clearly says one thing but does another. Because it is against the law to presell (and by the way, I did orally consult one of the leading FDA enforcers, and he confirmed that the agency has not changed its view), the agency should not ignore a blatant violation, I’m guessing, just because the agency thinks the technology is cool.

Personally, I think this new generation of mobile apps and accessories are extremely cool and offer a tremendous public health opportunity. These are very exciting times. But I also think developers of these new tools need to bring their products to market it in the right way, with respect for the rules, or those rules need to change for everyone. 

Brad Thompson is a member of the firm at Epstein Becker & Green, P.C., where he counsels medical device, drug, and combination product companies on a range of FDA regulatory, reimbursement, and clinical trial issues. He also heads up the firm's Connected Health Initiative, and blogs for mobihealthnews.com. 






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