Hello Julie,
Well you are being philosophical now. In my limited discussions with FDA personnel, they consider EVERYTHING inside the hospital or doctors office to be a medical device if it is promoted for that use in the least way, and if it is not a drug. That is their authority and they are sticking to it. Tongue depressors, pre-printed laboratory order forms, etc. All are devices. These companies may never get inspected. FDA may not lift a finger to pursue violators. But that doesn't change the fact that they could.
In cases where enough reasonable people think the costs clearly exceed any possible value, FDA might eventually concede that there is not much to be gained. So sometimes the agency says OK, the device is "not actively regulated". It may be noted in guidance documents or in company specific 513(g) responses. In the not so distant past an email from the agency might have sufficed. Were those the good old days?
PS - If I were in the regulator's shoes I would probably adopt the same vigorous approach.
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David Ledwig, RAC, CQA
Principal Consultant
Practical Compliance, LLC
ledwigd@practicalcompliance.comO (828) 862-8555
M - (828) 508-6535
Original Message:
Sent: 02-Dec-2016 15:23
From: Julie Omohundro
Subject: Are these medical devices? Why or Why Not?
Thanks, David. I'm really pondering the broader question of what FDA considers a medical device, and, more so, why. These devices just happen to catch my eye; there are some other devices regulated by FDA that I have wondered about as well. I'm not sure what disease would be addressed by these three devices. The full definition of medical device includes "...or other condition," but that just raises more questions for me.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
Original Message:
Sent: 01-Dec-2016 10:42
From: David Ledwig
Subject: Are these medical devices? Why or Why Not?
Hello Julie,
The products, as presented, are devices because they meet FDA's definition of a medical device in that they are "used" in diagnosis, cure, mitigation, treatment, or prevention of disease (http://www.fda.gov/AboutFDA/Transparency/Basics/ucm211822.htm). Given the possibility that products like these might be used as a marketing or sales tool vs. strictly for patient education, I think there is some legitimate concern.
Many low risk devices are Class I and some are "not actively regulated". Having followed the medical imaging industry for twenty years and being familiar with the explosion in applications I would be glad to discuss them with you.
Kind regards,
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David Ledwig, RAC, CQA
Principal Consultant
Practical Compliance, LLC
ledwigd@practicalcompliance.com
O (828) 862-8555
M - (828) 508-6535
Original Message:
Sent: 30-Nov-2016 21:37
From: Julie Omohundro
Subject: Are these medical devices? Why or Why Not?
I would be interested to know whether forum members think these software products meet FDA's definition of a medical device (or, perhaps more important, whether FDA would think they meet its definition) and, especially, why or why not:
https://www.crisalix.com/en
http://www.illusioimaging.com/
Also, can anyone shed some light on why FDA regulates examination gowns as a medical device? Is their some medical purpose for which these gowns are used? Or is the medical purpose found in "during a medical examination"?
(a) Identification. An examination gown is a device intended for
medical purposes that is made of cloth, paper, or other material that is
draped over or worn by a patient as a body covering during a medical
examination.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
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