FDA Steps up Oversight on Medical Apps

When the U.S. Food & Drug Administration sent a warning letter to an Indian app developer in late May, entrepreneurs in this country took notice. The FDA warned Biosense Technologies Private Ltd. that its app which is designed to work with a urine-testing kit is actually a medical device, and therefore it must be cleared by the agency. The large and growing community of doesn’t expect this to be the last time the FDA weighs in on mobile apps marketed for health-related uses. “There are millions of medical apps out there. The industry is concerned,” says Gabriel Vorobiof, a Los Angeles cardiologist and co-founder of PadInMotion, a New York company developing mobile tools for hospital use. “It’s just not clear how far the FDA will go.”

Until now, the FDA has taken a largely hands-off approach to medical apps, but that could change any day. In July 2011, the agency published a draft of proposed rules for medical app developers and posted it online so the public could comment on it. Releasing the final version of those rules “is a priority for the agency and we are working to publish a guidance document this year,” a spokesperson said in an email.

Most app developers are not shocked that the FDA is cracking down on Biosense. That’s because the company markets its app, called uChek, as a tool for analyzing urine-testing strips. The FDA approves the use of those strips—but only if interpreted by a “direct visual reading.” Once the mobile phone becomes the chief analyzer of the test results, the entire test system, including the app, must get separate clearance, the agency said in its letter to Biosense. “That’s not surprising,” says Brad Weinberg, a partner with New York-based Blueprint Health, an incubator for medical technology startups. “Any regulated diagnostic test or medical device needs to get approved,” even if it’s a variation of an already-approved tool.

In an email, Biosense founder Abhishek Sen says he won’t comment on the content of the FDA’s letter, except to say, “We are in touch with the U.S. FDA, and will be working closely with them over the coming months to ensure that we continue to deliver accurate, affordable and convenient diagnostics across the world.” What about apps that don’t make diagnoses, but still provide personalized information based on specific patients and their medical conditions? That’s where the FDA’s oversight could get murky. The draft guidance suggests that when apps are designed to collect information about specific patients and use it to, say, assist physicians in calculating the proper dosage of a drug, they may be subject to FDA oversight.

Nicholas Genes, an assistant professor of emergency medicine at Mount Sinai School of Medicine in New York and a frequent blogger on medical apps, says it’s fine if the FDA steps in to ensure that new technology protects patient safety and privacy, but he’ll be concerned if the agency oversteps its bounds. “If a couple of programmers have a cool idea, I would hope that the FDA doesn’t stifle that, because these are the people that are driving the whole market,” Genes says. Judging from the draft guidance, many makers of health-related apps should be immune from FDA oversight. They will likely include PadInMotion because it provides access to apps via the tablet computers it makes available to hospitals but doesn’t actually develop any apps itself. The draft guidance also states that apps providing wellness tools, such as nutrition advice and exercise tips, won’t have to be approved.

For those entrepreneurs who are subject to FDA scrutiny, however, the process can be daunting. Ryan Sysko, co-founder and CEO of Baltimore-based WellDoc, says his company spent more than two years getting FDA clearance for its first product, a diabetes app designed to help patients interact with their physicians in managing their medications, glucose testing and lifestyle choices.

Sysco says he suspected the technology would need to gain FDA approval from the time the company launched in 2005, because it was designing an app that physicians would prescribe like a drug or device. “The existing regulations were relatively clear,” Sysco says. “If you look at the software regs that were written in the 1970s, we felt the types of feedback and support we were going to give patients would make us a device.” Weinberg says he advises entrepreneurs participating in Blueprint Health with the FDA and their legal advisors early in the startup process so they can clarify regulatory requirements and be prepared for any resulting time and expense. And like many in his industry, he’s eagerly awaiting the final word from the FDA. “It would be helpful if the FDA would be clear about its guidance,” he says.

Calculate the price
Make an order in advance and get the best price
Pages (550 words)
$0.00
*Price with a welcome 15% discount applied.
Pro tip: If you want to save more money and pay the lowest price, you need to set a more extended deadline.
We know how difficult it is to be a student these days. That's why our prices are one of the most affordable on the market, and there are no hidden fees.

Instead, we offer bonuses, discounts, and free services to make your experience outstanding.
How it works
Receive a 100% original paper that will pass Turnitin from a top essay writing service
step 1
Upload your instructions
Fill out the order form and provide paper details. You can even attach screenshots or add additional instructions later. If something is not clear or missing, the writer will contact you for clarification.
Pro service tips
How to get the most out of your experience with MyhomeworkGeeks
One writer throughout the entire course
If you like the writer, you can hire them again. Just copy & paste their ID on the order form ("Preferred Writer's ID" field). This way, your vocabulary will be uniform, and the writer will be aware of your needs.
The same paper from different writers
You can order essay or any other work from two different writers to choose the best one or give another version to a friend. This can be done through the add-on "Same paper from another writer."
Copy of sources used by the writer
Our college essay writers work with ScienceDirect and other databases. They can send you articles or materials used in PDF or through screenshots. Just tick the "Copy of sources" field on the order form.
Testimonials
See why 20k+ students have chosen us as their sole writing assistance provider
Check out the latest reviews and opinions submitted by real customers worldwide and make an informed decision.
Business and administrative studies
Thank you for your hard work
Customer 452773, October 19th, 2023
ACC543MANAGERIALACCOUNTINGANDLEGALASPECTS
excellent
Customer 452773, January 25th, 2024
FIN571
excellent work
Customer 452773, March 1st, 2024
Business and administrative studies
excellent job!
Customer 452773, May 25th, 2023
Criminal Justice
This has been the greatest help while I am recovering from an illness. Thank your team so much.
Customer 452671, May 2nd, 2021
History
Looks great and appreciate the help.
Customer 452675, April 26th, 2021
Management
Thank you!!! I received my order in record timing.
Customer 452551, February 9th, 2021
English 101
IThank you
Customer 452631, April 6th, 2021
10th grade English
very good
Customer 452773, March 26th, 2023
History
Don't really see any of sources I provided, but elsewise its great, thank you!
Customer 452697, May 8th, 2021
Nursing
I just need some minor alterations. Thanks.
Customer 452547, February 10th, 2021
Leadership Studies
excellent job as always
Customer 452773, September 2nd, 2023
11,595
Customer reviews in total
96%
Current satisfaction rate
3 pages
Average paper length
37%
Customers referred by a friend
OUR GIFT TO YOU
15% OFF your first order
Use a coupon FIRST15 and enjoy expert help with any task at the most affordable price.
Claim my 15% OFF Order in Chat
Close

Sometimes it is hard to do all the work on your own

Let us help you get a good grade on your paper. Get professional help and free up your time for more important courses. Let us handle your;

  • Dissertations and Thesis
  • Essays
  • All Assignments

  • Research papers
  • Terms Papers
  • Online Classes
Live ChatWhatsApp