Should Mobile Medical Apps Require FDA Approval?

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BBINDER000,
User Rank: Apprentice
10/26/2011 | 7:43:21 PM

re: Should Mobile Medical Apps Require FDA Approval?

I've worked extensively in both development of FDA regulated devices and mobile app testing. I've recently blogged about both questions:

D+�j+� vu All Over Again G�� The Mobile Testing Nightmare
http://www.robertvbinder.com/b...

Competent, Mediocre, or Dangerous?
http://www.robertvbinder.com/b...

The short version: I think the FDA has gotten the general requirements for developing high reliability software-intensive products about right, but the onus for achieving this high quality is on the development organizations. There is wide variation in interpretation, which can lead to inadequate development practices.

I don't see any essential difference in the general requirements for developing high quality systems with mobile endpoints. However, verification and validation of a system with mobile endpoints is *more* difficult than a wired client/server system, other things being equal. Owing to lack of experience, many assume that mobile endpoints are easier to develop/test.

The new FDA Guidance delimits when mobile platforms are considered as part of regulated system or not. I don't see anything in the guidance that calls for a different approach to developing, verifying, or validating included systems. The criteria for inclusion of a mobile endpoint seems to be that if it supports a feature which is regulated, then the mobile endpoint is also regulated.

I hope that developers using mobile end-points for regulated systems will take the unique challenges of mobile in to account in planning their V&V.

Bob Binder

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Lisa Henderson,
User Rank: Apprentice
10/27/2011 | 1:29:11 AM

re: Should Mobile Medical Apps Require FDA Approval?

I agree with you Paul .... I think the FDA does get a bad rap and when it tries to overcorrect, as may have happened with some of the drug regulations you mention, it can cause a lot of time, money and resources for the pharmaceutical companies. But truly, in the end, with drugs and with applications, those that will help with proven effectiveness and safer patients.

Lisa Henderson, InformationWeek Healthcare, contributing editor

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MedicalQuack,
User Rank: Moderator
10/31/2011 | 6:47:55 PM

re: Should Mobile Medical Apps Require FDA Approval?

Certainly there's a bit of caution when technologies with Big Data capabilities are fed information to query from...approach with caution...

http://ducknetweb.blogspot.com...

There's a lot of flawed data out there right now and if this is all sent to data bases for search, it somewhat defeats the purpose...Numbers don't lie but people do...

http://ducknetweb.blogspot.com...

The FDA needs more engineers just all business does to accomplish this project too, I don't know who doesn't get this part of the equation, other than our Congress who has a proven record of digital illiteracy. They too need Big Data tech to make better laws.

http://ducknetweb.blogspot.com...

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RCORPUS000,
User Rank: Apprentice
10/31/2011 | 8:07:39 PM

re: Should Mobile Medical Apps Require FDA Approval?

"The new FDA guidelines may create headaches for developers, but there is an upside for doctors and patients. "
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Help determining whether registration exclusions apply and, if not, we will prepare and submit your registrations with U.S. FDA and make changes, updates and cancellations as needed at no extra cost.
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