Grapefruit USA Inc (GPFT)

[Chemic76spirit]

Want to know about INTENDED USE STATEMENTS? From YAHOO: Info for your DD pleasure!

The intended use or indications for use of a product are the claims that the company wants to make about the product after approval. http://myraqa.com/intended_use_statement...

By FDA regulation, 21 C.F.R. § 801.4, the intended use of a device refers “to the objective intent of the persons legally responsible for the labeling of device.” Thus, the intended use is controlled by the company’s own words.

The definition does go on to say that the intended use can be established by known off-label use of the device. That portion of the regulation, which has created considerable confusion, can essentially be ignored.

The intended use is determined by the applicant, not by subsequent third party use. If FDA believes that a device that is the subject of a 510(k) premarket notification is likely to be used off-label and that a particular use may present health risks, FDA can mandate a warning against that use. FDA cannot, however, reject a 510(k) because of anticipated off-label use.

The intended use will delineate and circumscribe the company’s ability to promote its IVD. All “labeling” must be consistent with the intended use.

Labeling is broadly defined by law, and covers virtually all promotional materials created or distributed by the company or its agents. Oral communications, such as statements by sales representatives, must also be consistent with the intended use statement. Claims that go beyond the labeled intended use are deemed off-label and can result in FDA enforcement action.

Thus, submitting an application for a narrow, unmarketable intended use simply to obtain FDA clearance can result in a commercial dead end. The product may lawfully be sold, but the ability to promote it would be fatally constrained.

Intended use should not be drafted solely with the input of regulatory personnel. Sales and marketing personnel should provide guidance, as well. Companies must consider the potential impact of the intended use on the commercial success of the product.

The FDA regulatory process will culminate in an approval or clearance for a clearly defined intended use. The final labeling will explicitly state the product’s intended use.
http://www.genengnews.com/articles/chite...

For a fantastic flow chart on Intended Use Statements by the FDA see... http://www.fda.gov/MedicalDevices/Device...


4. Indications for Use Statement
We recommend that you use this section to provide the indications for use statement, which is a document where you identify and describe the specific indications for use statement for the device(s) included in the 510(k) submission. Your indications for use statement should be exactly the same as the indications for use listed throughout the rest of your 510(k) submission, including the indications for use in the device labeling. We believe that in order for FDA to adequately review your submission you should identify whether the device is intended for prescription use and/or over-the-counter use.http://www.fda510k.com/510k-sections-and...


Come to your own conclusions....

me...Long & Strong... Rating :
(1 Rating)Rate it: