What Defines a Medical Device?

If the iPhone was an anvil, and application developers repurposed a hammer into a medical device when used with the anvil....would the anvil and hammer be regulated by the FDA?

Products such as these should not be regulated.

1. They are 'Client' or 'Viewer' type products, and should not be considered to be medical 'scientific' tools of inquiry and evaluation about human medical health.

2. They are still far more advanced than medical tools of say 1980's era, and so all they should have to do is comply with an ISO (Not FDA) type of manufacturing quality program. (which I'm sure they are anyway)

3. Any medical device is valuable and operational, not by its design parameters, but by regular calibration and maintenance, so perhaps that could be considered, if it is going to be used for consultation by a medical practitioner for evaluating human health.. but not for personal use... disclaimers to be used otherwise.

4. The FDA doesn't give a hoot about human health anyway.. just the dollars they get from being in bed with pharmaceutical companies.

5. There are hundreds of tools for use by physicians that are not regulated. Real effective medical knowledge is properly placed in the hands of a well trained medical professional. What you want to do is to ensure that professional is well trained in the use and maintenance of the tools and systems they use.. otherwise it is a waste of resources, and you will simply shut down the creative work being done by companies such as Apple. Don't fack with the goose that is laying the golden eggs.

Chris

"The FDA has indicated the iPhone may be deemed a medical device and regulated as such in some cases."

Following this line of thinking perhaps ball point pens used by doctors to write prescriptions or make entries into medical charts should also be regulated. A poorly functioning pen could contribute to a degree of illegibility that results in a prescription being filled incorrectly and being a factor in the death of a patient.

ROFL at the absurdity of this.......Ed Weldon

A hazard analysis will tell what are the effects on a course of treatment due to malfunctioning of the device or intentional or involuntary misuse by the operator.

If there are no hazards at all regulation may not be needed.

Bioramani

If my doctor gets out an iphone to diagnose my illness then i will be heading for the door and getting another doctor. The iphone cannot, and never will, be a medical device whatever the app's installed!

Does the FDA regulate Microsoft and Intel because the doctor has a PC on his desk?

The FDA should try and deal with what they already have instead of trying to add additional stuff into their realm. For gods sake look at the amount of people that die/ are seriously harmed by drugs regulated by the FDA.

Oh what a tangled web we weave.....

I saw a German made patient monitor that was engineered to meet Hewlett Packard's requirements have to be re engineered because of UL The UL issues got pretty ridiculous. I know this, the more agencies involved, the more screwed up the issues get.

Having said that, I believe that sticking a device in the middle of a medical system should make it technically a part of that system and not an unrelated accessory. I've been surprised before by finding an Apple 2E computer (complete with floppy drives) inside things such as a vascular flow analysis system and a control system for a large coal plant. Both systems' keyboards were the only parts visible. Where do you draw that line?

In the case of a custom system, then I could see the system having to be qualified as per a quality system. That means planning, engineering, documentation, testing, and records of performance, and training. (and customer satisfaction)

Any component of the system just needs to be a product on the 'approved vendors list' and hopefully have a quality program of their own. If the plan and engineering calls for an Apple 2E as part of the design, then that is equivalent to a resistor or sheet metal screw... it is qualified by the appropriate engineering staff. specification, traceability, calibration, and maintenance are the name of the game. not appearance or age or regulation... (unless dealing with regulated products like nuclear sources) thats the line.

as I said before, it does not require FDA regulation, any more than a hospital does.

Chris

To determining if an article is a "medical device" under customs law in Canada one need only look to see if the manufacturer, importer, vendor or advertising makes any medical claim about the device. As far as your post about the iPhone, it would not be considered a medical device, the applications you mentioned however might be.

Articles are generally subject to control if the public is led to believe that the article provides some medical benifit. Take certain "herbal" products which are not regulated. The packaging, advertising and attached literature makes no claim as to medical properties or benifits. If some purchasers choose to believe that the product does in fact cure cancer that is not the issue, the products are not marketed for that purpose and the manufacturer has no control over what is done with their product once in the hands of the end user. As soon as the package contains a claim that the product treats or alleviates some medical condition it comes under control of the feds.

I'm sure there is already a perfectly good (FDA) definition of 'medical device'.
Many medical devices interface with peripherals such as printers.
The burden of compliance rests with both if there is 'patient contact'.
If there is no patient contact, then the burden of compliance should rest with original medical device, not the peripheral.
The peripheral will of course still have to copmply to appropriate national safety specs.

Del

This is what US FDA has to say on this issue:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm

bioramani

Land line phones with coupling have been used to transmit EKG and Pacemaker data for over 20 years. There has never been a requirements for the coupling device or "Ma-Bells" equipment to be subject to FDA monitiring of a medical device. Medical devices subject to FDA regulations must by their purpose measure a biologic parameter. The platform for transmitting stored or real time data, so long as it does not make contact with the patient is not classified as medical equipment. Another example of non-medical equipment that carries medical equipment and serves only as a platform and as such not FDA regulated are land and air ambulances. The FDA has a difficult time just regulating what it is required to regulate if additional requirements are placed then the only people who will loose is the consumer for additional cost of being regulated as a medical device. A medical stool costs $250.00 and the identical off the shelf stool not used in medical environment costs $50.00. As a biomedical engineer and physician, my opinion is we don't need to drive up the cost of medicai care further by classifying an iphone as medical equipment so that the health insurance companies will pay for them as we text and make calls while driving.