"Indication for Use" used in 510(k) - Indications for Use vs. Intended Use

[temujin]

Dear Forum,

Is the term "Indication for Use" used in 510(k) equal to the terms "Intended Use"/"Intended Purpose"

regards
temu

[chris1price]

Hi

In my experince, the Indications for Use are usually very specific and tend to be used in a regulatory framework, such as discussion with FDA on predicates or labelling. The indended use is more general and descriptive.

see

http://www.fda.gov/cdrh/devadvice/314312.html#link_6

***DEAD LINK REMOVED****

[yodon]

The kicker I've seen is that any statement of intended use can be construed by the FDA as "indication for use." Just about anything published can be taken as labeling so if your 510(k) limits indication for use but you have, for example, marketing literature that expands that use, the FDA can consider the broader statement as a claim. Bottom line is to be careful!

[Madly RA'd Woman]

This is one of the statements you can find in the ANSI/AAMI/ISO TIR14969:2004 (guidance towards ISO 13485) document about the two terms:

7.2.1.3 For medical devices, an understanding of both stated intended use and any reasonably foreseeable misuse, and indications for use, should be documented. This is of particular importance in the development of new products. The guidance in 7.3 will help the organization to determine if requirements for design and development apply. The stated intended use and any reasonably foreseeable misuse should also be included in risk management activities (see 7.1 of this document regarding risk management activities).

I see this statement contrasting the "intended use" with "foreseeable misuse". "Indications for use" is more of the specific scenarios in which the device may be applied.

I also agree with the previous log that stated to be careful with your application remarks. If you aren't a RAPS member, you may want to check with RAPS.org about this subject. Anywhere you state what your product does is a "labelling" that is FDA reviewable and peer-debatable.

If you stray from your 510(k) permissable indications, you will have regulatory work to do beyond any labelling changes.

Hope this helps!

[cookie36]

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 (and throughout the submission under intended use as well)

- Indications for use: is the more detailed version of the intended use. 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.

This is confusing to me because what we submit with the 510k is known as the indications for use - but is this really known as the "intended use"?

-Elaine

[sagai]

There is a wind of change recently in this subject, see:
http://www.fda.gov/downloads/AboutFD.../UCM220784.pdf
Page 7.

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Sz.