Once upon a time the U.S. Food and Drug Administration, or FDA, was a very zealous organization monitoring and enforcing the toughest quality and safety standards, for food, drugs and medical devices, which made the USA pharmaceutical and medical industry the most highly respected one in the world.
Not even European countries, which have always competed with the USA in order to demonstrate that they have higher standards, could ever surpass this country regarding quality and safety assurance for medical devices.
In South America where regulations, even though they exist, they are hardly enforced, most medical device purchases would refer to the USA FDA approval seal to ensure quality and above all safety. Please note that this was not required by law but it was simply the right thing to do. Even vendors would use the FDA approval as a competitive advantage to sell their products.
The FDA is an agency within the Department of Health and Human Services.
“The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, expands the FDA’s authorities and strengthens the agency’s ability to safeguard and advance public health.”
“The Health Information Technology for Economic and Clinical Health (HITECH) Act supports the development of a nationwide health IT infrastructure.”
The HITECH Act empowers the Office of the National Coordinator for Health Information Technology(ONC) to build an interoperable, private and secure nationwide health information system and supporting the widespread, meaningful use of health information technology.
The ONC is organizationally located within the Office of the Secretary for the U.S. Department of Health and Human Services (HHS).
What could we conclude from the above HHS agencies or offices?
Well, one acts as a traffic cop for medical devices, among other things, and the other one has orders to push technology at a fast rate. Apparently, we have put a traffic cop in the middle of an NASCAR race. There seems to be a conflict of interests here.
Albeit an unintended consequence, since the FDASIA clearly expands the FDA’s authorities and strengths, the FDA seems to have a weakened authority to enforce the adequate processes that manufactures should adhere to in order to build, release and advertise medical devices to the market.
Congress has pressured the FDA in order to not contribute to the stifling of the technological advancement.
We have a situation where an enforcing agency [FDA] is unable to act due to external political pressures.
Meanwhile, many have been abusing this weakened authority and lack of autonomy. The press is chalk-full of news regarding “digital snake oil“.
But, what exactly is a medical device?
Per the FDA 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,
- 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 its 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.“
Many mobile medical apps are claiming to do precisely what medical devices are for, that is, detect or diagnose a disease or other conditions.
For the FDA it’s easy to control medical devices that have to go through rigorous processes in order to be marketed. Even if they are being manufactured overseas they have to go through certain “physical” gateways before they are promoted and marketed in the USA. The conventional devices have to be transported,traverse customs, acquire other permits and clearances (e.g.; FCC), before they reach the distribution channels.
The FDA can also audit or request the companies in the US soil to prove that they follow a quality control process following international standards for quality management systems, such as: ISO-13485.
Before a medical device is even marketed in the US, that is, the simple announcing it to the public with the intent of selling it, the product must obtain a FDA Premarket Approval (PMA) or a 510(k) Clearance.
Medical apps on both Android and Apple platforms have become ubiquitous, these are classified as Mobile Medical Applications by the FDA.
Even controlling the Apple or Google stores by requiring them to act as proxies by enforcing regulations could be easily circumvented. And from a layman’s perspective this seems like a legal impossibility.
Apple has some control over the apps you download but you can do anything on an Android. And if medical device apps get blocked by Apple most of those interested more in the apps than the niche segment, will just move to the competitors.
But how would the FDA control the “manufacturing” of mobile medical apps when they can be delivered through the Internet from any location in the world. The user could simply download the app and install it on their phone or tablet.
The FDA has no authority outside of the USA. How can the FDA stop a mobile health app being developed in Eastern Europe or in China from being downloaded into a smartphone here in the USA?
Another fact is that entrepreneurs move fast, and technology is changing at a speed never witnessed before and this is only going to get much more aggressive in the near future. On the other hand, the FDA moves slowly, and most times with the best intentions in mind. The FDA was created to protect the American People from harm produced by inadequate and untested medical devices or drugs.
Entrepreneurs have on their side congress members like Rep. Chris Collins (R-N.Y.).
These technology advocates understand that if the FDA becomes a hindrance for American entrepreneurs, the USA is going to lose its technological vantage point to other countries that impose little or no restriction on mobile medical apps.
This may be the reason why the FDA has been performing more the role of guidance than of enforcement relating to mobile medical apps.
Postmarket Management of Cybersecurity in Medical Devices – Draft Guidance for Industry and Food and Drug Administration Staff
If the FDA pushes too hard on this recent technological rising, the USA will lose ground to foreign competition and our market will not be protected unless the Internet is closed to the outside world and we know this will never happen.
The fact of the matter is that this is not an easy problem to solve.
Could it be that the FDA has gone obsolete?