When will the FDA drop the gavel?

By: Brian Dolan | Nov 19, 2009        

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Brian Dolan, Editor, MobiHealthNewsBack in February we reported that the Food & Drug Administration (FDA) had just begun its conversation with the mobile health industry and that the ways in which it would regulate this emerging industry would come out of that conversation.

It’s now November and those working on wireless health are getting antsy. When will the FDA weigh-in?

For the past few months, Bradley Merrill Thompson, Partner at Epstein Becker & Green, has penned contributed articles for MobiHealthNews that outline how the FDA might regulate wireless health under its existing system.

“At a high-level, we look for two things: (1) a device with (2) a medical intended use. The first prong of the test — that there must be an actual product — means FDA doesn’t regulate, for example, medical procedures. The thing in question must be a thing, and not information or something else intangible. Software can be a medical device if it’s written on computer media, as opposed to printed on paper. The media with the code written on it is enough of a ‘thing’ for FDA to regulate,” Thomspon writes. “In the area of mobile health technology, it’s important to understand that an accessory or a component of a medical device is itself a regulated medical device. Further, the difference between an accessory and a component is who buys it. End-users buy accessories, while manufacturers buy components. Thus the exact same piece of equipment could be either an accessory or a component depending on the target purchaser.”

To get a better understanding of the FDA’s potential role in regulating wireless health, be sure to read Thompson’s article on Mobile Phones and Certain Accessories and also Thompson’s Step-by-Step Guide to Wireless Health Regulation.

Just this week the medical technology blog MedGadget wrote that the “U.S. FDA and other regulatory agencies are far behind the times that we live in, so they have no current policies to deal with the proliferation of mobile computing devices and their potential uses in medicine. Hence, none of the iPhone applications and attachments are classified as medical devices, so they are sold for nonmedical uses only.”

Of course, the AirStrip OB iPhone app has already attained FDA clearance, but what about the other iPhone apps intended for use in clinical settings? Many of them would qualify for FDA regulation under Thompson’s analysis.

It’s become a common refrain from those wireless health device makers and service providers who have already gone through FDA clearance: Soon the FDA will swoop in and regulate medical apps for smartphones.

We are beginning to wonder: Will the regulatory gavel fall in 2010?

  • David Albert, MD

    The FDA is in the beginning of a major review of the entire 510(k) process so if you are looking for quick action–forget it. The FDA has domain over medical products and has classifications: Class 1 like bp devices bought at CVS, Class 2 like ECG machines in hospitals and Class3 like pacemakers. Many wireless health devices will be Class 2. I believe Cardionet and other wireless cardiac monitoring products are considered Class 2. The Airstrip OB application is part of a system which includes the interface to the fetal monitoring data (via a maternal-fetal Clinical Information System which has already been FDA’d which interfaces to the fetal monitor which has been FDA’d), the “server” and the application. Airstrip had to show data integrity (it is allowable to show no data but not bad data). Over 12 years ago, I received a 510(k) for a product that was an ecg monitoring device that used a PDA. Those precedents have been set. People should stop griping and get to work understanding things like GMPs, clinical validation, IRBs, and the 510(k) process.

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  • David Albert, MD

    Big difference between these two recommendations. The mammography recommendation was NOT DONE BY CLINICIANS while the PAP smear rec was done by ACOG– the docs who care for cervical cancer. Another thought that clearly impacted this decision is that the HPV vaccine will continue to have increased penetration in younger women who are not sexually active (or maybe are) and they will be at a significantly lower risk of cervical cancer anyway. Clearly , clinical decisions should be made by clinicians using the best data provided by research but not made by statisticians looking at that same data– they have no accountability vis a vis the patient.

  • Frank Poggio

    While the FDA is still thinking about medical software, ONCHIT, the Office of the National Coordinator for Health Information Technology is moving ahead. ONCHIT was created by CMS as part of the ARRA HiTECH Act of last year. Smart medical devices that add /change /delete PHI or clinical data will have to get ONCHIT certified or you will not be able to sell them to any health facility. On a purely regulatory basis your software does not have to be ceritfied, but from a marketing and sales perspecitive it will be. Hospitals and physician offices will not be eligible for Meaningful Use bonuses, or will be subject to MU penalties if they do not run certified systems…or their certified systems tie into non-certified systems.
    More info at: http://www.kelzongroup.com/ONCHIT.html