Artur, I agree that argument can be made, but I'm inclined to think CDRH is loathe to make it, or it would find itself having to regulate all sorts of products it doesn't want to regulate. At the same time, it probably doesn't want to give it up, so it can use it if a situation arises that it comes in handy. In short, it's just bad language.
GIven all that, I'm inclined to agree with the way CDRH has mostly resolved this quandary, which is to add "in patients, healthcare providers, or a healthcare environment." By that logic, as long as it is not for use by a definable patient population (e.g., those in rehab), it is probably not a medical device.
Of course, whether it is or is not a medical device will not be resolved by a majority vote in the RAPS Forum. :)
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 23-Jan-2020 11:08
From: Artur Shchukin
Subject: FDA Registration Advice Required
I believe it would still be under medical device since it falls under:
intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and
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Artur Shchukin RAC, MS, ASQ-CQA
Manager, RA/QA
New York NY
United States
Original Message:
Sent: 18-Jan-2020 11:45
From: Anonymous Member
Subject: FDA Registration Advice Required
This message was posted by a user wishing to remain anonymous
Hi
I'm working with a client who has developed a pneumatic tourniquet for blood flow restriction training. The intended use for the product is"for use on the limbs of healthy individuals to improve or facilitate muscular performance." My view is that as this does not have a medical purpose it doesn't meet the definition of a medical device in the US and so would not need to be registered in the US. Am I correct in this assumption? Also can anyone advise if there are any other additional US regulations that sports products need to meet?
With a medical claim it would probably fall under 21 CFR Part 878.5910, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=878.5910. Devices under this part of the regulation are intended to be utilised during surgery and are Class I exempt. There is no intention by the company to include a claim for use during surgery but the company may want to add a rehabilitation claim that the device treats injuries and speeds up recovery at some point in the future. With this claim would the device be considered to have a medical purpose in the US? If so would it fall under 21 CFR Part 878.5910? There is no other regulation that I can find which would apply to the product.
Thank you in advance for your help with this.