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510(k), gmdn codes, indications for use, product code, user manuals, intended use (medical devices)
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  #1  
Old 5th August 2010, 12:14 PM
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Please Help! Indications for Use vs. Intended Use in User Manual

We would like to put both our indications for use and intended use in our user manual.

Is this safe to say:

- Intended use: is the same statement as what we submit in the 510(k) in the "indications for use" page that is made public

- Indications for use: is the more detailed version of the intended use (above). It could be made up, or summarize, the other portions of the 510(k), going into even more detail as to the contraindications, disease states, patient populations, etc.

Or, is the intended use a very general statement, and could even be derived from a GMDN code, or product code, and the "Indications for use" statement is the copy/paste of the indications for use page in the 510(k)?

Please help!
-Elaine

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Old 5th August 2010, 01:41 PM
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Re: Indications for Use vs. Intended Use in User Manual

http://medicaldeviceschool.com/A00002.html.......check this link for an article on the subject. I dont fully agree with any of the 3 possibilities you posed above. It is somewhat tricky and dependent on your type of product. I recommend reading this comprehensive article for starters.
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Old 5th August 2010, 01:42 PM
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Re: Indications for Use vs. Intended Use in User Manual

http://medicaldeviceschool.com/index.html
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Old 5th August 2010, 04:45 PM
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Re: Indications for Use vs. Intended Use in User Manual

Thanks for that article. It was very helpful.

From the article, is it safe to say, in general:

The products " indications for use " is usually the same statement we submit to the FDA (ie. in the 510k).

The intended use may be more vague and really based on the image of our product and what our promotional material, labeling and claims may be, etc.

-Elaine
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Old 6th August 2010, 01:07 AM
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Re: Indications for Use vs. Intended Use in User Manual

suggested recent article
Page7 @
http://www.fda.gov/downloads/AboutFD.../UCM220784.pdf

br
Sz.

br
Sz.
Thank You to sagai for your informative Post and/or Attachment!
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Old 6th August 2010, 01:30 PM
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Re: Indications for Use vs. Intended Use in User Manual

Thanks. A great document and it highlights the confusion even amongst FDA reviewers with regard to intended or indications for use.
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Old 20th August 2010, 09:27 PM
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Re: Indications for Use vs. Intended Use in User Manual

There's an old (1997) FDA draft guidance document on medical device labeling format and content that I do not believe is available on the FDA web site, but which I have a copy. It states:

"Intended Use" refers to the functional capability of the device. It also refers to the objective intent of the person legally responsible for the labeling of the device.

"Indications" are the disease(s) or condition(s) the device will diagnose, treat, prevent, cure, or mitigate and a description of the target population ...

An example might be a medical laser:

Intended Use - soft tissue ablation
Indications for Use - ablation of (name the tissue or disease being treated).

BYW - this issue likely will go away. The FDA's recent report on proposed 510(k) reform highlights the confusion over these terms. I believe that the FDA's working group recommendation was/is to eliminate the "Indications for Use" term and combine the requirements noted above into an "Intended Use" term (or vice versa, I can't recall).
Thanks to meddev1 for your informative Post and/or Attachment!
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Old 21st August 2010, 02:51 AM
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Re: Indications for Use vs. Intended Use in User Manual

Please refer below FDA’s definition of indented use & indication for use

21 CFR 801.4 Meaning of intended uses:

“The words intended uses or words of similar import in 801.5, 801.119, and 801.122 refer to the objective intent of the persons legally responsible for the labeling of devices. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he received the devices, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses. But if a manufacturer knows, or has knowledge of facts that would give him notice that a device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a device which accords with such other uses to which the article is to be put”.

A regulatory concept that affords FDA considerable discretion to get involve in labeling, promotion, advertising, and device design. Also Defined as “…the objective intent of the persons legally responsible for the labeling of devices…”

21 CFR 814.20(b)(3)(i) Indications for use:

“A general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended”.

Indications for Use do not depict a device’s entire intended use.

Regards
S. Subramaniam
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